ICD10-Mapping for Osteoarthritis | IPS | icd 10 code for left knee osteoarthritis[/caption]
icd 10 code for left knee osteoarthritis
Summary of PMA Originals & Supplements Approved Originals: 4 Supplements: 101
[caption id="" align="aligncenter" width="638"]
Anesthesiology Medical Billing – Learn the Top 10 ICD-10 Codes | icd 10 code for left knee osteoarthritis[/caption]
Summary of PMA Originals Beneath Review Total Beneath Review: 51 Total Active: 26 Total On Hold: 25
Summary of PMA Supplements Beneath Review Total Beneath Review: 513 Total Active: 373 Total On Hold: 140
Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 101 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 131.9 FDA Time: 103.2 Days MFR Time: 28.7 Days
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
N16895/S0945/2/14135-Day
Soflens 38 (polymacon) bendable acquaintance lenses
Bausch & LombRochester, NY 14609
Approval for an added supplier for the raw actual hydroxyethyl-methyl-methacrylate for polymacon and alphafilcon A bendable acquaintance lenses.
P830055/S1435/23/14Special
LCS® Total Knee System
DePuy Orthopaedics, IncorporatedWarsaw, IN 46582
Approval for an added analysis footfall in the accomplishment action for the Distal and Posterior Augments and the Revision Footfall Wedges that provides added affirmation of purity, identity, backbone or believability of the device.
P830060/S0775/2/14Real-Time
AID-B/BR and Ventak ICD
Boston Scientific CorporationSt. Paul, MN 55112
Approval to add the use of mineral oil to accessory labeling.
P850048/S0375/1/14Real-Time
Access Hybritech PSA Reagents on the Admission Immunoassay Systems
Beckman Coulter, Inc.Chaska, MN 55318
Approval for software changes to add action ecology functionality to the accepted agreement of the Admission 2 Immunoassay Arrangement through the accomplishing of a new software adaptation 3.4.1.
P860003/S0755/9/14Real-Time
THERAKOS® CELLEX® Photopheresis System
THERAKOS, Inc.Bridgewater, NJ 08807
Approval for a change in the geometry of the stand-offs featured on the close lower basin awning of the CELLEX® Procedural Kit’s centrifuge bowl.
P860057/S1215/19/14Real-Time
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis,Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon Pericardial Mitral Bioprosthesis, Carpentier-Edwards PERIMOUNT Magna Mitral Pericardial Bioprosthesis, Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis
Edwards Lifesciences, LLCIrvine, CA 92614
Approval for advance the printed ambit lath (PCB) of the Sensitech agAlert® temperature indicator with accessory accouterments enhancements.
P870056/S0675/19/14Real-Time
Carpentier-Edwards Beefy Aortic Bioprosthesis, Carpentier-Edwards Beefy Mitral Bioprosthesis, Carpentier-Edwards Bioprosthetic Valved Conduit
Edwards Lifesciences, LLCIrvine, CA 92614
Approval for advance the printed ambit lath (PCB) of the Sensitech agAlert® temperature indicator with accessory accouterments enhancements.
P870077/S0615/19/14Real-Time
Carpentier-Edwards Duraflex Low Pressure Beefy Mitral Bioprosthesis, Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis with Extended SutureRing
Edwards Lifesciences, LLCIrvine, CA 92614
Approval for advance the printed ambit lath (PCB) of the Sensitech agAlert® temperature indicator with accessory accouterments enhancements.
P880006/S0885/29/14Real-Time
SENSOLOG/ DIALOG/ REGENCY PACEMAKERS
St. Jude MedicalSunnyvale, CA 94085
Approval for the Model 3330 Adaptation 18.1.1 Software for the Merlin Patient Care Arrangement Programmer Model 3650.
P880086/S2425/29/14Real-Time
AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENTPACEMAKERS
St. Jude MedicalSunnyvale, CA 94085
Approval for the Model 3330 Adaptation 18.1.1 Software for the Merlin Patient Care Arrangement Programmer Model 3650.
P890003/S3055/16/14Real-Time
REVEAL DX. REVEAL XT, REVEAL LINQ INSERTABLE CARDIAC MONITOR
Medtronic, Inc.Mounds View, MN55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a array of built-in devices.
P890003/S3065/23/14Real-Time
My CareLink Patient Monitor
Medtronic, Inc.Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P890003/S3075/29/14Real-Time
My CareLink Patient Monitor
Medtronic, Inc.Mounds View, MN 55112
Approval for accessory accouterments and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Arch for the devices.
P890055/S0555/22/14Special
MedStream Programmable Infusion System
Codman & Shurtleff, Inc.Raynham, MA02767
Approval for changes to affection ascendancy and accomplishment procedures to accommodate added accomplish acceptance that a minimum of 66 hours accept delayed amid the time that the MedStream pump array is affiliated to the Printed Ambit Lath (PCB) and afore programming the PCB with the accumulation analytic pump software.
P890064/S0305/12/14Real-Time
Qiagen Digene Amalgam Capture 2 (HC2) HPV DNA Test; Qiagen Digene Amalgam Capture 2 (HC2) Aerial Risk HPV DNA Test
Qiagen Gaithersburg, Inc.Gaithersburg, MD 20878
Approval for the advancement of the HC2 Software Suite to Adaptation 4.2.
P900009/S0355/29/14180-Day
EXOGEN Ultrasound Bone Healing System
Bioventus LLCDurham, NC 27703
Approval for a new Bioventus accomplishment ability in Cordova, Tennessee, accomplishment action changes, a rechargeable array and charger, redesign of the capital operating unit, changes to the instructions for use, and adapted packaging.
P900009/S0365/7/14180-Day
Exogen Ultrasound Bone Healing System
Bioventus LLCDurham, NC 27703
Approval for a accomplishment armpit in Cordova, Tennessee.
P910023/S3335/29/14Real-Time
ELLIPSE/FORTIFY ASSURA IMPLANTABLE CARDIOVERTERDEFIBRILLATORS
St. Jude MedicalSunnyvale, CA 94085
Approval for the Model 3330 Adaptation 18.1.1 Software for the Merlin Patient Care Arrangement Programmer Model 3650.
P910073/S1245/2/14Real-Time
ENDOTAK RELIANCE 4-SITE Defibrillation Leads
Boston Scientific CorporationSt. Paul, MN 55112
Approval to add the use of mineral oil to accessory labeling.
P910077/S1415/2/14Real-Time
VENTAK PRx, VENTAK MINI ICDs
Boston Scientific CorporationSt. Paul, MN 55112
Approval to add the use of mineral oil to accessory labeling.
P940015/S0285/20/14135-Day
Synvisc and Synvisc-One
Nancy ImmelGenzyme CorporationCambridge, MA 02142
Approval for changes to affection ascendancy analysis methods.
P940031/S0765/2/14Real-Time
VIGOR, MERIDIAN, DISCOVERY Pacemakers
Boston Scientific CorporationSt. Paul, MN 55112
Approval to add the use of mineral oil to accessory labeling.
P950037/S1325/4/14180-Day
ENTOVIS PROMRI PACEMAKER SYSTEM
Biotronik, Inc.Lake Oswego, OR 97035
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the acknowledging Programmer Software Adaptation PSW 1307.U. Back an Entovis Pacemaker is acclimated in affiliation with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be articular as the Entovis ProMRI System.
P960022/S0095/2/14135-Day
Soflens Toric (alphafilcon A) bendable Acquaintance Lenses
Bausch & LombRochester, NY 14609
Approval for an added supplier for the raw actual hydroxyethyl-methyl-methacrylate for polymacon and alphafilcon A bendable acquaintance lenses.
P960040/S3105/2/14Real-Time
VENTAK AV, VENTAK PRIZM, VITALITY, CONFIENT, TELIGEN, INCEPTA, ENERGEN, PUNCTUA ICDs
Boston Scientific CorporationSt. Paul, MN 55112
Approval to add the use of mineral oil to accessory labeling.
P960040/S3125/15/14Real-Time
Teligen, Punctua, Energen, and Incepta Implanable Cardioverter Defibrillators (ICD) and Punctua, Energen, and Incepta Cardiac Resynchronization Analysis Defibrillators (CRT-D)
Boston Scientific CorporationSt. Paul, MN 55112
Approval for changes in trace azure ascendancy absolute in raw MnO2 and trace calcium ascendancy absolute in raw lithium antithesis for the beating architect batteries.
N970003/S1595/2/14Real-Time
PULSAR, PULSAR MAX, DISCOVERY, INSIGNIA, ALTRUA,INGENIO, ADVANTIO, VITALIO, FORMIO Pacemakers
Boston Scientific CorporationSt. Paul, MN 55112
Approval to add the use of mineral oil to accessory labeling.
N970003/S1605/15/14Real-Time
Advantio and Ingenio Pacemakers
Boston Scientific CorporationSt. Paul, MN 55112
Approval for changes in trace azure ascendancy absolute in raw MnO2 and trace calcium ascendancy absolute in raw lithium antithesis for the beating architect batteries.
P970013/S0585/29/14Real-Time
MICRONY PACEMAKERS
St. Jude MedicalSunnyvale, CA 94085
Approval for the Model 3330 Adaptation 18.1.1 Software for the Merlin Patient Care Arrangement Programmer Model 3650.
P970029/S0265/7/14Special
TMR2000 Holmium Laser System
CardiogenesisKennesaw, GA 30144
Approval for including the Post Approval abstraction labeling changes of the Pearl 8.0 accessory into the instructions for use of the Pearl 5.0 and the Sologrip III handpieces as able-bodied as abacus some allegorical statements to ensure the safe administration of the handpieces.
P970003/S1665/9/14180-Day
VNS Analysis System
Cyberonics, Inc.Houson, TX 77058
Approval for labeling that describes the altitude beneath which Magnetic Resonance Imaging (MRI) can be acclimated back balance VNS Leads or Advance bits (abandoned leads) abide in the body.
P970038/S0265/1/14Real-Time
Access Hybritech Free PSA Reagents on the Admission Immunoassay Systems
Beckman Coulter, Inc.Chaska, MN 55318
Approval for software changes to add action ecology functionality to the accepted agreement of the Admission 2 Immunoassay Arrangement through the accomplishing of a new software adaptation 3.4.1.
P970051/S1105/8/14180-Day
Nucleus 24 Cochlear Implant System
Cochlear AmericasCentennial, CO 80111
Approval for a change to the accumulation architecture of alien switches on the CP810 complete processor with the ambition of convalescent admission aegis and accordingly bane resistance.
P980006/S0155/16/14180-Day
PureVision 2 (balafilcon A) Visibility Tinted Acquaintance Lens;PureVision 2 for Astigmatism (balafilcon A) Visibility Tinted Acquaintance Lens; PureVision 2 for Presbyopia (balafilcon A) Visibility Tinted Acquaintance Lens
Bausch & Lomb, Inc.Rochester, NY 14609
Approval for an alternating packaging band-aid of borate buffered acrid with 0.5% poloxamine for the balafilcon A acquaintance lens artefact family.
P980016/S4725/16/14Real-Time
EnTrust, Virtuoso, Intrinsic, Marquis, Maximo, Maximo II, Secura, Virtuoso II, InsyncMarquis, Protecta XT DR, Protecta DR, Protecta XT VR, Protecta VR, Evera XT DR,Evera S DR, Evera XT VR, and Evera S VR
Medtronic, Inc.Mounds View, MN55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a array of built-in devices.
P980016/S4745/13/14Real-Time
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD
Medtronic, Inc.Mounds View, MN 55112
Approval for a Replacement Telemetry M Basic and Associated Accomplishment Changes.
P980016/S4775/23/14Real-Time
EVERA, INTRINSIC, MARQUIS, MAXIMO, PROTECTA, SECURA, AND VIRTUOSO II IMPLANTABLE CARDIOVERTERDEFIBRILLATORS (ICD)
Medtronic, Inc.Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P980016/S4785/29/14Real-Time
Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Intrinsic 30, Intrinsic, Marquis DR, Marquis VR, Maximo DR, Maximo II, Maximo VR, Protecta, Protecta XT, Secura, Virtuoso II DR/VR Ancestors of ICDs
Medtronic, Inc.Mounds View, MN 55112
Approval for accessory accouterments and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Arch for the devices.
P980016/S4795/23/14Real-Time
Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD
Medtronic, Inc.Mounds View, MN 55112
Approval for the changes of the anamorphosis aspect (DE) in the aerial voltage capacitor electrical feedthrough for the devices.
P980022/S1535/29/14Real-Time
Paradigm REAL-Time Revel System
Medtronic MiniMedNorthridge, CA 91325
Approval for software changes to the Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-523K, MMT-723, and MMT-723K) appliance software. These changes accommodate corrections for two motor absurdity anomalies and enhancements for the Threshold Suspend feature, insulin amount setting, and alloyed accepted cipher base. The Paradigm REAL-Time Revel Insulin Pump is a basic of the Paradigm REAL-Time Revel System.
P980035/S3695/16/14Real-Time
Advisa DR IPO, Advisa DR MRI IPG
Medtronic, Inc.Mounds View, MN55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a array of built-in devices.
P980035/S3725/23/14Real-Time
ADAPTA, VERSA, SENSIA, ADVISA, ENPULSE, AND KAPPAIMPLANTABLE PULSE GENERATORS (IPG)
Medtronic, Inc.Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P980035/S3735/29/14Real-Time
Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, EnPulse E1, EnPulse E2, Kappa D, Kappa DR, Kappa SR (Kappa 700 and Kappa 900), Kappa VDD (Kappa 700) ancestors of IPGs
Medtronic, Inc.Mounds View, MN 55112
Approval for accessory accouterments and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Arch for the devices.
P980041/S0275/1/14Real-Time
Access AFP Reagents on the Admission Immunoassay Systems
Beckman Coulter, Inc.Chaska, MN 55318
Approval for software changes to add action ecology functionality to the accepted agreement of the Admission 2 Immunoassay Arrangement through the accomplishing of a new software adaptation 3.4.1.
P990009/S0375/27/14180-Day
Floseal Hemostatic Matrix
Baxter Healthcare CorporationRound Lake, IL 60073
Approval for revised labeling to accommodate a arbitrary of the Nasso et al. analytic trial, amend the accessory description, and extend the Thrombin reconstitution period.
P990081/S0285/6/14Real-Time
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc.Tucson, AZ 85755
Approval for a new adhering for the accelerate heaters on the BenchMark XT and ULTRA automatic accelerate stainers.
P000006/S0345/5/14180-Day
Titan Inflatable Penile Prosthesis
Coloplast CorporationMinneapolis, MN 55411
Approval for an added raw actual supplier for the polyurethane spandex actual acclimated in the artifact of Bioflex® burning (used to accomplish Titan reservoirs and cylinders).
P000007/S0465/19/14Real-Time
Edwards Prima Plus Stentless Beefy Bioprosthesis
Edwards Lifesciences, LLCIrvine, CA 92614
Approval for advance the printed ambit lath (PCB) of the Sensitech agAlert® temperature indicator with accessory accouterments enhancements.
P000009/S0575/4/14180-Day
Xelos DR-T Implantable CardioverterDefibrillators (ICD’s)
Biotronik, Inc.Lake Oswego, OR 97035
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the acknowledging Programmer Software Adaptation PSW 1307.U. Back an Entovis Pacemaker is acclimated in affiliation with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be articular as the Entovis ProMRI System.
P000029/S0765/8/14135-Day
Deflux
Salix Pharmaceuticals, Inc.Raleigh, NC 27615
Approval for the accession of centralized produced baptize for bang (WFI), as able-bodied as approval for the use of biologic brand NaOH and HCl, rather than the brand currently acclimated by the firm.
P010012/S3475/2/14Real-Time
CONTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, INCEPTA, ENERGEN, PUNCTUA CRT-Ds
Boston Scientific CorporationSt. Paul, MN 55112
Approval to add the use of mineral oil to accessory labeling.
P010012/S3495/15/14Real-Time
Cognis Cardiac Resynchronization Analysis Defibrillators (CRT-D)
Boston Scientific CorporationSt. Paul, MN 55112
Approval for changes in trace azure ascendancy absolute in raw MnO2 and trace calcium ascendancy absolute in raw lithium antithesis for the beating architect batteries.
P010013/S0545/30/14180-Day
NovaSure Impedance Controlled Endometrial Ablation System
Hologic, Inc.Marlborough, MA 01752
Approval of the post-approval abstraction protocol.
P010015/S2365/16/14Real-Time
CONSULTA CRT-P, SYNCRA CRT-P
Medtronic, Inc.Mounds View, MN55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a array of built-in devices.
P010015/S2375/23/14Real-Time
CONSULTA AND SYNCRA CARDIAC RESYNCHRONI- ZATION THERAPY PACEMAKERS
Medtronic, Inc.Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P010015/S2385/29/14Real-Time
Consulta CRT-P, Syncra CRT-P
Medtronic, Inc.Mounds View, MN 55112
Approval for accessory accouterments and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Arch for the devices.
P010030/S049 5/19/14Real-Time
LifeVest® Wearable Defibrillator
ZOLL Lifecor CorporationPittsburgh, PA 15238
Approval for 29 RoHS adjustable alternating components, 7 RoHS adjustable alternating bare-board subassemblies, and 6 RoHS adjustable alternating cable subassemblies for use in the LifeVest Wearable Defibrillator.
P010031/S4335/16/14Real-Time
Maximo II CRT-D, Concerto, Concerto II CRT-D, Consulta, InSync II Marquis, InSync IIIMarquis, InSync Maximo, InSync Sentry, InSync Marquis, InSync II Protect, Protecta CRT-D,Protecta XT CRT-D, Viva XT CRT-D, Viva S CRT-D, and Brava CRT-D
Medtronic, Inc.Mounds View, MN55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a array of built-in devices.
P010031/S4355/13/14Real-Time
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D
Medtronic, Inc.Mounds View, MN 55112
Approval for a Replacement Telemetry M Basic and Associated Accomplishment Changes.
P010031/S4385/23/14Real-Time
BRAVA, CONCERTO, CONSULTA, INSYNC, MAXIMO II,PROTECTA, AND VIVA CARDIAC RESYNCHRONI- ZATIONTHERAPY DEFIBRILLATORS (CRT-D)
[caption id="" align="aligncenter" width="960"]
ICD-10-CM: PRL Training Session 5 Practice Resources, LLC ppt download | icd 10 code for left knee osteoarthritis[/caption]
Medtronic, Inc.Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P010031/S4395/29/14Real-Time
Brava CRT-D, Concerto ICD, Concerto II CRT-D, Consulta ICD, InSync II Protect ICD, InSync III Marquis ICD, InSync Maximo ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRT-D
Medtronic, Inc.Mounds View, MN 55112
Approval for accessory accouterments and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Arch for the devices.
P010031/S4405/23/14Real-Time
Brava CRT-D; Viva S CRT-D; Viva XT CRT-D
Medtronic, Inc.Mounds View, MN 55112
Approval for the changes of the anamorphosis aspect (DE) in the aerial voltage capacitor electrical feedthrough for the devices.
P010041/S0505/19/14Real-Time
Carpentier-Edwards S.A.V. Aortic Beefy Bioprosthesis
Edwards Lifesciences, LLCIrvine, CA 92614
Approval for advance the printed ambit lath (PCB) of the Sensitech agAlert® temperature indicator with accessory accouterments enhancements.
P020055/S0145/6/14Real-Time
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc.Tucson, AZ 85755
Approval for a new adhering for the accelerate heaters on the BenchMark XT and ULTRA automatic accelerate stainers.
P030004/S0065/27/14180-Day
Onyx™ Liquid Embolic Arrangement (LES)
Micro Therapeutics, Inc. d/b/a ev3 NeurovascularIrvine, CA 92618
Approval for the Apollo™ Onyx™ Delivery Micro Catheter that will be bogus at Micro Therapeutics, Inc. d/b/a ev3 Neurovascular in Irvine, California.
P030005/S1065/2/14Real-Time
CONTAK RENEWAL TR, INVIVE, INTUA CRT-Ps
Boston Scientific CorporationSt. Paul, MN 55112
Approval to add the use of mineral oil to accessory labeling.
P030005/S1075/15/14Real-Time
Invive Cardiac Resynchronization Analysis Pacemakers (CRT-P)
Boston Scientific CorporationSt. Paul, MN 55112
Approval for changes in trace azure ascendancy absolute in raw MnO2 and trace calcium ascendancy absolute in raw lithium antithesis for the beating architect batteries.
P030017/S1865/22/14180-Day
Precision Spectra SCS System
Boston Scientific CorporationValencia, CA 91355
Approval for architecture changes to Precision Spectra OR Cable and Addendum and an alternating able supplier (Onanon Inc. Milpitas, CA).
P030035/S1205/29/14Real-Time
FRONTIER/FRONTIER II/ ANTHEM CARDIACRESYNCHRONI-ZATION THERAPY-PACEMAKERS
St. Jude MedicalSunnyvale, CA 94085
Approval for the Model 3330 Adaptation 18.1.1 Software for the Merlin Patient Care Arrangement Programmer Model 3650.
P030054/S2655/29/14Real-Time
QUADRA ASSURA/UNIFY ASSURA CARDIACRESYNCHRONI-ZATION THERAPY-DEFIBRILLATORS
St. Jude MedicalSunnyvale, CA 94085
Approval for the Model 3330 Adaptation 18.1.1 Software for the Merlin Patient Care Arrangement Programmer Model 3650.
P050010/S0145/28/14180-Day
PRODISC L Total Disc Replacement
DePuy Synthes SpineRaynham, MA 02767
Approval to add added endplates as a band extension.
P050023/S0745/4/14180-Day
Ilesto implantable cardioverterdefibrillators (ICD’s) and cardiac resynchronization analysis defibrillators (CRT-D’s)
Biotronik, Inc.Lake Oswego, OR 97035
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the acknowledging Programmer Software Adaptation PSW 1307.U. Back an Entovis Pacemaker is acclimated in affiliation with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be articular as the Entovis ProMRI System.
P050050/S0075/9/14180-Day
Scandinavian Total Ankle Replacement Arrangement (S.T.A.R. Ankle)
Small Bone Innovations, Inc.Morrisville, PA19067
Approval of the post-approval abstraction protocol.
P060019/S0255/19/14180-Day
Therapy Cool Path Ablation Catheter & IBI-1500T9 RF Architect – Cool Point™ Tubing Set
Irvine Biomedical, Inc.Irvine, CA 92614
Approval for a architecture change in the tubing set actual and amalgamation admeasurement for the Cool Point™ Tubing Set.
P060037/S0275/13/14135-Day
NexGen LPS Flex Mobile Bearing Knee
Zimmer, IncorporatedWarsaw, IN 46581
Approval for new testing equipment.
P060037/S0285/22/14135-Day
NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee
Zimmer, IncorporatedWarsaw, IN 46581
Approval for accession of a new accomplishment breadth with new equipment.
P070008/S0505/4/14180-Day
Evia cardiac resynchronization therapypacemakers (CRT-P’s)
Biotronik, Inc.Lake Oswego, OR 97035
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the acknowledging Programmer Software Adaptation PSW 1307.U. Back an Entovis Pacemaker is acclimated in affiliation with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be articular as the Entovis ProMRI System.
P070015/S1195/29/14135-Day
XIENCE V® Everolimus Eluting Coronary Stent Arrangement (RX and OTW);XIENCE nano™ Coronary Stent Arrangement (RX)
Abbott VascularTemecula, CA 92589
Approval for a change in the adhering agreement of polypropylene accumulation items acclimated in XIENCE album and biologic conception manufacturing.
P070026/S0215/19/14180-Day
Ceramax Ceramic Hip System
Depuy, Inc.Warsaw, IN 46581
Approval of the post-approval abstraction protocol.
P080006/S0635/15/14180-Day
Attain Ability Lead
Medtronic CRDMMounds View, MN 55112
Approval for changes to the caked controlled absolution accessory (MCRD) elution adjustment and specifications, alteration of the MCRD accomplishment location, use of a agent tip basic for MCRD testing, and updates to the MCRD shelf activity agreement for Attain Ability advance models 4196, 4296 and 4396.
P090013/S1365/16/14Real-Time
Revo MRI
Medtronic, Inc.Mounds View, MN55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a array of built-in devices.
P090013/S1385/23/14Real-Time
REVO MRI IPG
Medtronic, Inc.Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P090013/S1395/29/14Real-Time
Revo MRI IPG
Medtronic, Inc.Mounds View, MN 55112
Approval for accessory accouterments and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Arch for the devices.
P090026/S0105/1/14Real-Time
Access Hybritech p2PSA Reagents on the Admission Immunoassay Systems
Beckman Coulter, Inc.Chaska, MN 55318
Approval for software changes to add action ecology functionality to the accepted agreement of the Admission 2 Immunoassay Arrangement through the accomplishing of a new software adaptation 3.4.1.
P100003/S0035/8/14180-Day
Secure-C Artificial Cervical Disc
Globus Medical, Inc.Audubon, PA 19403
Approval of the post-approval abstraction protocol.
P100009/S0055/22/14Special
MitraClip & Clip Delivery System
Abbott VascularMenlo Park, CA 94025
Approval for a labeling change that included additions to the account of advancing contest and converting assertive procedural attention statements to admonishing statements.
P100014/S0125/12/14135-Day
Solesta
Salix Pharmaceuticals, Inc.Raleigh, NC 27615
Introduction of centralized produced baptize for bang (WFI).
P100021/S0355/13/14Special
Endurant and Endurant II Stent Graft System
Medtronic VascularSanta Rosa, CA 95403
Approval for clarifications fabricated to the rear handle accumulation accomplishment action procedures.
P100021/S0365/14/14Special
Endurant and Endurant II Stent Graft System
Medtronic VascularSanta Rosa, CA 95403
Approval for accessory clarifications to the hydrophilic blanket procedures.
P100023/S0805/19/14135-Day
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System
Boston ScientificMaple Grove, MN 55311
Approval to abate the Kinetic Biologic Absolution (KDR) sample abundance for accumulation absolution and adherence testing.
P100026/S0115/7/14Real-Time
RNS® System
NeuroPace, Inc.Mountain View, CA 94043
Approval for the accession of Ethernet connectivity to admission the Patient Data Management Arrangement database.
P100027/S0175/6/14Real-Time
INFORM HER2 Bifold ISH DNA Probe
Ventana Medical Systems, Inc.Tucson, AZ 85755
Approval for a new adhering for the accelerate heaters on the BenchMark XT and ULTRA automatic accelerate stainers.
P100029/S0155/8/14135-Day
Trifecta™ Valve
St. Jude Medical, Inc.St. Paul, MN 55117
Approval for an alternating bacterial endotoxin sampling/testing plan for the Trifecta™ valve.
P100041/S0505/19/14Real-Time
Edwards SAPIEN Transcatheter Heart Valve and Accessories
Edwards Lifesciences, LLCIrvine, CA 92614
Approval for advance the printed ambit lath (PCB) of the Sensitech agAlert® temperature indicator with accessory accouterments enhancements.
P110002/S0015/27/14180-Day
Mobi-C Cervical Disc
LDR Spine USA, Inc.Austin, TX 78750
Approval of the post-approval abstraction protocol.
P110004/S0025/1/14Real-Time
NIRxcell CoCr Coronary Stent on RX System
Medinol Ltd.Tel Aviv, Israel61581
Approval for a modification to the D-catheter tip spring.
P110009/S0015/19/14180-Day
Mobi-C Cervical Disc
LDR Spine USA, Inc.Austin, TX 78750
Approval of the post-approval abstraction protocol.
P110009/S0025/8/14180-Day
Mobi-C Cervical Disc
LDR Spine USA, Inc.Austin, TX 78750
Approval of the post-approval abstraction protocol.
P110014/S0025/15/14180-Day
MarginProbe System
Dune Medical, Ltd.Caesarea Industrial Park, Israel38900
Approval for a accomplishment armpit amid at Medimor Ltd., in Tiberias, Israel (contract manufacturer).
P110019/S0605/29/14135-Day
XIENCE PRIME® Everolimus Eluting Coronary Stent Arrangement (RX);XIENCE PRIME® Everolimus Eluting Coronary Stent System, LL (RX);XIENCE XPEDITION™ Everolimus Eluting Coronary Stent Arrangement (RX and OTW); XIENCE XPEDITION™ Everolimus Eluting Coronary Stent System, SV (RX and OTW); XIENCE XPEDITION™ Everolimus Eluting Coronary Stent System, LL (RX and OTW)
Abbott VascularTemecula, CA 92589
Approval for a change in the adhering agreement of polypropylene accumulation items acclimated in XIENCE album and biologic conception manufacturing.
P110021/S0375/19/14Real-Time
Edwards SAPIEN Transcatheter Heart Valve and Accessories
Edwards Lifesciences, LLCIrvine, CA 92614
Approval for advance the printed ambit lath (PCB) of the Sensitech agAlert® temperature indicator with accessory accouterments enhancements.
P850010/S0525/7/14
Helistat, Helitene Absorbable Collagen Hemostatic Agents
Integra Activity Sciences CorporationPlainsboro, NJ 08536
Qualification of a new AirLock Room.
P850022/S0225/9/14
Biomet OrthoPak Non-invasive Bone Growth Stimulator Arrangement & Biomet SpinalPak Non-invasive Spine Fusion Stimulator System
EBI, LLC, d/b/a Biomet Spine & Bone Healing TechnologiesParsippany, NJ 07054
Addition of new labeling equipment.
P850068/S0105/14/14
Silsoft® (elastofilcon A) Acquaintance Lenses
Bausch & Lomb, Inc.Rochester, NY 14609
Acceptance of an alternating autoclave.
P850068/S0115/8/14
Silsoft (Elastofilcon A) Acquaintance Lens
Bausch & Lomb, Inc.Rochester, NY 14609
Replacement of the laser carving system.
P860057/S1235/1/14
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprostheses
Edwards Lifesciences, LLCIrvine, CA 92614
Addition of an alternating tissue supplier.
P860057/S245/13/14
Carpentier-Edwards PERIMOUNT Pericardia Aortic and Mitral Bioprosthesis
Edwards Lifesciences, LLCIrvine, CA 92614
Upgrade of the valve breeze and advertisement coaptation tester.
P870078/S0255/19/14
Hancock® Low Porosity Valved Conduit
Medtronic Heart ValvesSanta Ana, CA 92705
Addition of new beefy tissue suppliers.
P890003/S3085/2/14
MyCareLink Patient Monitor
Medtronic, Inc.Mounds View, MN 55112
Test changes to the telemetry module.
P900033/S0345/7/14
Integra Dermal Regeneration Template
Integra Activity Sciences CorporationPlainsboro, NJ 08536
Qualification of a new AirLock Room.
P900056/S1375/1/14
Rotablator Rotational Atherectomy System
Boston Scientific CorporationMaple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P900056/S1385/5/14
Rotablator Rotational Atherectomy System
Boston Scientific CorporationMaple Grove, MN 55311
Change to the Incoming Analysis armpit for the Rotablator Console apparatus from Fremont, California to San Jose, California.
P910007/S0435/16/14
ARCHITECT Total Free PSA
Abbott Laboratories Abbott Park, IL 60064
Revision of the affection ascendancy analysis adjustment to acquiesce the AxSYM Total and Free PSA analysis methods to be replaced by the ARCHITECT Total and Free PSA analysis methods for the accomplish of PSA Panel H.
P910007S0445/28/14
ARCHITECT Total PSA
Abbott Laboratories, Abbott Park, IL 60064
Changes to the affection ascendancy testing acclimated to appraise the adequacy of in-process ARCHITECT Total PSA aggregate accessory calibrator abstracts and ARCHITECT Free PSA aggregate artefact calibrator/ ascendancy materials.
P910023/S3345/19/14
FORTIFY AND FORTIFY ASSURA FAMILIES OF ICD DEVICES
St. Jude MedicalSylmar, CA 91342
Change to the chip ambit basic rework procedure.
P910023/S3355/23/14
Current DR, Accepted DR RF, Accepted Accel DR, Accepted DR, Accepted VR, Accepted VR RF, Accepted Accel VR, Accepted VR, Ellipse DR, Ellipse VR, Fortify DR, Fortify VR, Fortify Assura DR, Fortify Assura VR
St. Jude MedicalSylmar, CA 91342
Use of an alternating electrolyte supplier for the aerial voltage capacitors acclimated in the devices.
P910062/S0045/30/14
STAR S41R Excimer Laser Arrangement and WaveScan WaveFront System
AMO Accomplishment USA, LLCMilpitas, CA 95035
Change of the Frame Grabber Printed Ambit Lath (PCB) of the STAR system.
P910062/S0065/30/14
STAR S4 IR Excimer Laser Arrangement and WaveScan WaveFront System
AMO Accomplishment USA, LLCMilpitas, CA 95035
Addition of a re-polishing action for the Hex Prism assembly, of the STAR system.
P910073/S1255/7/14
ENDOTAK TRANSVENOUS DEFIBRILLATION SYSTEM
Boston Scientific CorporationSt. Paul, MN 55112
Add an identical Sterilization Alcove to the St. Paul accomplishment facility.
P910077/S1425/7/14
VENTAK PRX AICD SYSTEM. PRESCRIPTOR PROGRAMMER AND PROGRAM AND PROGRAM DISK
Boston Scientific CorporationSt. Paul, MN 55112
Add an identical Sterilization Alcove to the St. Paul accomplishment facility.
P920047/S0695/1/14
Blazer II Cardiac Ablation Catheter and Cable
[caption id="" align="aligncenter" width="1920"]
ICD-10 Codes for Osteoarthritis of the Knee - YouTube | icd 10 code for left knee osteoarthritis[/caption]
Boston Scientific CorporationMaple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P920047/S0705/30/14
Blazer II, Blazer II HTD, Blazer Prime HTD Temperature AblationCatheters
Boston Scientific CorporationMaple Grove, MN 55311
Acceptance to alter an absolute chiral action with an automatic process.
P930016/S0405/30/14
STAR S41R Excimer Laser Arrangement and WaveScan WaveFront System
AMO Accomplishment USA, LLCMilpitas, CA 95035
Change of the Frame Grabber Printed Ambit Lath (PCB) of the STAR system.
P930016/S0425/30/14
STAR S4 IR Excimer Laser Arrangement and WaveScan WaveFront System
AMO Accomplishment USA, LLCMilpitas, CA 95035
Addition of a re-polishing action for the Hex Prism assembly, of the STAR system.
P930029/S0435/16/14
Atakr® Radio Frequency (RF) Catheter Ablation System
Medtronic, Inc.Mounds View, MN 55112
Change to the action controls on the allotment of a supplier to verify insulation amid thermocouple bifold wires.
P930031/S0525/23/14
WALLSTENT TIPS Endoprosthesis
Boston Scientific Corp.Maple Grove, MN 55311
Relocation of the accomplishment for the E-tube basic from one Boston Scientific Corporation ability to another.
P930035/S0265/7/14
VENTAK P2 AICD SYSTEM
Boston Scientific CorporationSt. Paul, MN 55112
Add an identical Sterilization Alcove to the St. Paul accomplishment facility.
P930039/S1085/28/14
CapSureFix Novus Lead
Medtronic CRDMMounds View MN 55112
Tip acid action advance for braid components.
P940008/S0315/7/14
RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS
Boston Scientific CorporationSt. Paul, MN 55112
Add an identical Sterilization Alcove to the St. Paul accomplishment facility.
P940015/S0325/14/14
Synvisc and Synvisc-One
Genzyme CorporationRidgefield, NJ07657
Addition of an automatic system.
P940019/S0445/23/14
WALLSTENT Iliac Endoprosthesis
Boston Scientific Corp.Maple Grove, MN 55311
Relocation of the accomplishment for the E-tube basic from one Boston Scientific Corporation ability to another.
P940031/S0775/7/14
VIGOR DR PACEMAKER SYSTEM/VIGOR SR PACEMAKER SYSTEM
Boston Scientific CorporationSt. Paul, MN 55112
Add an identical Sterilization Alcove to the St. Paul accomplishment facility.
P960004/S0655/7/14
THINLINE AND FINELINE TRANSVENOUS ENDOCARDIAL PACING LEADS
Boston Scientific CorporationSt. Paul, MN 55112
Add an identical Sterilization Alcove to the St. Paul accomplishment facility.
P960006/S0425/7/14
FLEXTEND PACING LEADS AND FIXATION TOOL
Boston Scientific CorporationSt. Paul, MN 55112
Add an identical Sterilization Alcove to the St. Paul accomplishment facility.
P960009/S1945/23/14
DBS Neurostimulators Implantable Activa Family
Medtronic, Inc.Minneapolis, MN 55432
Update the software acclimated at the Medtronic Tempe Campus.
P960011/S0245/27/14
BVI 1% Ophthalmic Viscosurgical Accessories (OVD)
Ferring Pharmaceuticals, Inc.Parisippany, NJ 07054
Use of a new average barge for BVI 1% and EUFLEXXA OVD.
P960040/S3135/1/14
PUNCTUA ICDs, TELIGEN ICDs, ENERGEN ICDs, INCEPTA ICDs
Boston Scientific CorporationSt. Paul, MN 55112
Manufacturing changes to the capacitor parylene measurement.
P960040/S3145/28/14
PUNCTUA ICDs; TELIGEN ICDs; ENERGEN ICDs; INCEPTA ICDs; ORIGEN ICDs; INOGEN ICDs; DYNAGEN ICDs
Boston Scientific CorporationSaint Paul, MN 55112
Use an alternating analysis adjustment and accessories with a agnate blueprint change.
P960040/S3155/23/14
DYNAGEN, INOGEN, ORIGEN ICDs
Boston Scientific CorporationSaint Paul, MN 55112
Addition of a added Beating Architect (PG) accessory attack overmolding Capital Band 2 at the Clonmel accomplishment facility.
P970020/S0805/13/14
MULTI-LINK ULTRA®/ MULTI-LINK ZETA® Coronary StentSystems
Abbott VascularTemecula, CA 92591
Addition of accepting analysis and testing activities of raw abstracts and accumulation items at the Clonmel, Ireland ability and arrangement laboratories.
P970031/S0455/19/14
Freestyle® Aortic Root Bioprosthesis
Medtronic Heart ValvesSanta Ana, CA 92705
Addition of new beefy tissue suppliers.
P970051/S1195/16/14
Nucleus 24 Cochlear Implant System
Cochlear AmericasCentennial, CO 80111
Acceptance of a new surgical apparatus supplier.
P980003/S0495/1/17
Chilli II Cooled Ablation Catheter and Cable
Boston Scientific CorporationMaple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P980007/S0345/16/14
ARCHITECT Free PSA
Abbott Laboratories Abbott Park, IL 60064
Revision of the affection ascendancy analysis adjustment to acquiesce the AxSYM Total and Free PSA analysis methods to be replaced by the ARCHITECT Total and Free PSA analysis methods for the accomplish of PSA Panel H.
P980007/S0355/13/14
ARCHITECT Free PSA
Abbott Laboratories, Abbott Park, IL 60064
Changes to affection ascendancy testing acclimated on in- action materials-ARCHITECT Free PSA aggregate accessory calibrators and ARCHITECT Free PSA aggregate artefact calibrators/controls.
P980016/S4805/2/14
Evera ICDs
Medtronic, Inc.Mounds View, MN 55112
Test changes to the telemetry module.
P980016/S4825/22/14
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD
Medtronic, Inc.Mounds View, MN 55112
Update to the Next Generation Amalgam Tester process.
P980016/S4835/30/14
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD
Medtronic, Inc.Mounds View, MN 55112
Change in the AVX capacitor lapping action acclimated in the devices.
P980022/S1555/14/14
Paradigm REAL-Time Continuous Glucose Ecology System, Paradigm REAL-Time Revel Continuous Glucose Ecology System,Guardian REAL-Time Continuous Glucose Ecology System
Medtronic MiniMedNorthridge, CA 91325
New apparatus to be acclimated in the action of abating the vibrator motor to the vibrator motor apartment in the Paradigm REAL-Time Insulin Pump (Models: MMT-522, MMT-522K, MMT-722, MMT-722K), a basic of the Paradigm REAL-Time Continuous Glucose Ecology System, the Paradigm REAL-Time Revel Insulin Pump (Models: MMT-523, MMT-523K, MMT-723, MMT-723K), a basic of the Paradigm REAL-Time Revel Continuous Glucose Ecology System, and the Guardian REAL-Time Continuous Glucose Ecology System.
P980033/S0415/23/14
WALLSTENT Venous Endoprosthesis
Boston Scientific Corp.Maple Grove, MN 55311
Relocation of the accomplishment for the E-tube basic from one Boston Scientific Corporation ability to another.
P980035/S3755/15/14
Advisa DR IPG, Advisa DR MRI IPG
Medtronic CRDMMounds View, MN 55112
Antenna wire band covering accomplishment acclimation for the devices.
P980035/S3765/29/14
Advisa DR and Advisa DR MRI IPGs
Medtronic, Inc.Mounds View, MN 55112
Changes to the aperture analysis system.
P980043/S0455/19/14
Hancock® II Beefy Bioprosthesis
Medtronic Heart ValvesSanta Ana, CA 92705
Addition of new beefy tissue suppliers.
P980044/S0185/30/14
SUPARTZ
Seikagaku CorporationTokyo, Japan100-0005
Addition of two new raw actual accumulator rooms.
P990010/S0045/30/14
STAR S41R Excimer Laser Arrangement and WaveScan WaveFront System
AMO Accomplishment USA, LLCMilpitas, CA 95035
Change of the Frame Grabber Printed Ambit Lath (PCB) of the STAR system.
P990010/S0065/30/14
STAR S4 IR Excimer Laser Arrangement and WaveScan WaveFront System
AMO Accomplishment USA, LLCMilpitas, CA 95035
Addition of a re-polishing action for the Hex Prism assembly, of the STAR system.
P990064/S0545/19/14
Mosaic® Beefy Bioprosthesis
Medtronic Heart ValvesSanta Ana, CA 92705
Addition of new beefy tissue suppliers.
P000020/S0185/16/14
Bard Ablation System
Boston Scientific CorporationLowell, MA 01851
Acceptance to apparatus an added supplier to accomplish machining of the ablation catheter handle components.
P000023/S0105/21/14
Fossa-Eminence and Condylar Prothesis System
Nexus CMF, LLCSalt Lake City, UT 84212
Add baptize affection standards.
P000029/S0775/21/14
Deflux Injectable Gel
Salix Pharmaceuticals, Inc.Raleigh, NC 27615
Expansion of the firm’s apple-pie allowance accumulation area.
P000035/S0105/21/14
TMJ Fossa-Eminence Prosthesis System
Nexus CMF, LLCSalt Lake City, UT 84212
Add baptize affection standards.
P010012/S3505/1/14
PUNCTUA CRT-D, COGNIS CRT-Ds, ENERGEN CRT-Ds, INCEPTACRT-Ds
Boston Scientific CorporationSt. Paul, MN 55112
Manufacturing changes to the capacitor parylene measurement.
P010012/S3515/12/14
INVIVE™ Cardiac Resynchronization Analysis Pacemaker (CRT-P); INTUA™ CRT-P
Boston Scientific CorporationSt. Paul, MN 55112
Adding an alternating Oscillator Crystal basic to amalgam bill of abstracts for the devices.
P010012/S3525/7/14
CONTAK CD CRT-D &EASYTRAK CORONARY VENOUS STEROID ELUTING SINGLE ELCTRODE PACE/SENSE LEAD
Boston Scientific CorporationSt. Paul, MN 55112
Add an identical Sterilization Alcove to the St. Paul accomplishment facility.
P010012/S3535/28/14
PUNCTUA CRT-Ds; COGNIS CRT-Ds; ENERGEN CRT-Ds; INCEPTA CRT-Ds; ORIGEN CRT-Ds; INOGEN CRT-Ds; DYNAGEN
Boston Scientific CorporationSaint Paul, MN 55112
Use an alternating analysis adjustment and accessories with a agnate blueprint change.
P010012/S3545/23/14
DYNAGEN, INOGEN, ORIGEN CRT-Ds
Boston Scientific CorporationSaint Paul, MN 55112
Addition of a added Beating Architect (PG) accessory attack overmolding Capital Band 2 at the Clonmel accomplishment facility.
P010013/S0555/14/14
NovaSure Impedance Controlled Endometrial Ablation System
Hologic, Inc.Marlborough, MA 01752
Change in the aperture analysis performed on the RF ambassador assorted subassembly.
P010015/S23905/29/14
Consulta and Syncra Cardiac Resynchronization Analysis – Pacemakers
Medtronic, Inc.Mounds View, MN 55112
Changes to the aperture analysis system.
P010015/S2405/28/14
Consulta CRT-P, Syncra CRT-P
Medtronic, Inc.Mounds View MN, 55112
Add an added accelerated band (USW) to affix the adapter sub-assembly to the radiopaque component.
P010029/S0205/27/14
EUFLEXXA Ophthalmic Viscosurgical Accessories (OVD)
Ferring Pharmaceuticals, Inc.Parisippany, NJ 07054
Use of a new average barge for BVI 1% and EUFLEXXA OVD.
P010031/S4415/2/14
Brava, Viva CRT-Ds
Medtronic, Inc.Mounds View, MN 55112
Test changes to the telemetry module.
P010031/S4445/22/14
Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D
Medtronic, Inc.Mounds View, MN 55112
Update to the Next Generation Amalgam Tester process.
P010031/S4455/30/14
Brava CRT-D, Concerto II CRT-D,Consulta ICD,Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D
Medtronic, Inc.Mounds View, MN 55112
Change in the AVX capacitor lapping action acclimated in the devices.
P010033/S0245/22/14
QuantiFERON®-TB Gold In-Tube
Cellestis IncorporatedValencia, CA 91355
Change to the breadth of accomplishment activities aural the aforementioned ahead accustomed enactment for the Arrangement Accomplishment Organization.
P020004/S0935/2/14
GORE® EXCLUDER® AAA Endoprosthesis
W.L. Gore & Associates, Inc.Phoenix, AZ 85085
Addition of an automatic bifold arch wrapper.
P020004/S0945/28/14
EXCLUDER AAA Endoprosthesis
W.L. Gore & Associates, Inc.Phoenix, AZ 85085
New supplier for biological indicators.
P020009/S1215/1/14
Express2 Monorail and OTW Coronary Stent System
Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P020025/S0575/1/14
Blazer II XP Cardiac Ablation Catheter and Cable
Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P020025/S0585/30/14
Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP Temperature AblationCatheters
Boston Scientific CorporationMaple Grove, MN 55311
Acceptance to alter an absolute chiral action with an automatic process.
P020036/S0285/12/14
SMART Ascendancy Nitinol Stent Systems
Cordis CorporationFremont, CA 94555
Change in accomplishment ability for the supplier of the slider accumulation and handle and the accession of a new abstraction machine.
P020045/S0535/14/14
Freezor, Freezor MAX and Freeze Xtra Cryoablation Devices
Medtronic CryoCath LPQuebec, CanadaH9R 5Z8
Change to the blazon of analysis catheter acclimated during Cryoconsole accomplishment and acreage accession testing.
P020047/S0085/13/14
MULTI-LINK VISION®/ MULTI-LINK MINI VISION®/MULTI-LINK 8® Coronary Stent Systems
[caption id="" align="aligncenter" width="960"]
Agenda ICD-10-CM ICD-10-PCS ICD-10 / 5010 transaction changes ... | icd 10 code for left knee osteoarthritis[/caption]
Abbott VascularTemecula, CA 92591
Addition of accepting analysis and testing activities of raw abstracts and accumulation items at the Clonmel, Ireland ability and arrangement laboratories.
P030002/S0315/13/14
Crystalens and Trulign Toric Intraocular Lens
Bausch & Lomb, Inc.Irvine, CA92618
Acceptance of a microbiological testing ability and the repurposing of a accomplishment room.
P030005/S1095/28/14
INVIVE CRT Ps; INTUA CRT Ps
Boston Scientific CorporationSaint Paul, MN 55112
Use an alternating analysis adjustment and accessories with a agnate blueprint change.
P030005/S1105/23/14
INVIVE, INTUA CRT-Ps
Boston Scientific CorporationSaint Paul, MN 55112
Addition of a added Beating Architect (PG) accessory attack overmolding Capital Band 2 at the Clonmel accomplishment facility.
P030009/S0775/2/14
Integrity Coronary Stent Systems
Medtronic Inc.Santa Rosa, CA 95403
Upgrade to the Wire Forming apparatus that is currently acclimated on Integrity stents.
P030009/S0785/23/14
Integrity Coronary Stent System
Medtronic VascularSanta Rosa, CA 95403
Change to the stent sub-assembly accomplishment equipment.
P030017/S1945/2/14
Precision Spectra Spinal Cord Stimulator System
Boston Scientific CorporationValencia, CA 91355
Add an alternating wire bonder.
P030017/S1955/2/14
Precision Spectra Spinal Cord Stimulator System
Boston Scientific CorporationValencia, CA 91355
Add an alternating able supplier for blubbery blur resistors.
P030022/S0305/30/14
REFLECTION Ceramic Acetabular Hip Arrangement (RCHS)
Smith & Nephew, Inc.Memphis, TN 38116
Introduce a new tray sealer to the packaging process.
P030054/S2665/19/14
QUADRA ASSURA, UNIFY, UNIFY ASSURA
St. Jude MedicalSylmar, CA 91342
Change to the chip ambit basic rework procedure.
P030054/S2675/23/14
Promote, PromoteAccel, Promote RF, Promote Q, PromoteQuadra, Promote ,Quadra Assura, Unify, Unify Assura, Unify Quadra
St. Jude MedicalSylmar, CA 91342
Use of an alternating electrolyte supplier for the aerial voltage capacitors acclimated in the devices.
P040016/S1275/1/14
VeriFLEX (Liberté) Coronary Stent System
Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P040027/S0335/28/14
VIATORR TIPS Endoprosthesis
W.L. Gore & Associates, Inc.Phoenix, AZ 85085
New supplier for biological indicators.
P040037/S0635/28/14
VIABAHN Endoprosthesis
W.L. Gore & Associates, Inc.Phoenix, AZ 85085
New supplier for biological indicators.
P040043/S0615/28/14
TAG Thoracic Endoprosthesis
W.L. Gore & Associates, Inc.Phoenix, AZ 85085
New supplier for biological indicators.
P040044/S0535/1/14
Mynx® Vascular Closure Accessory Artefact Family
Access Closure, Inc.Santa Clara, CA 95054
Implementation of a altered sterilization agreement for the Mynx® Artefact Ancestors of devices.
P040044/S0555/8/14
Mynx Vascular Closure Accessory Artefact Family
Access Closure, Inc.Santa Clara, CA 95054
Manufacturing action changes for acid and dehydration the Hydrogel cakes of the Mynx Vascular Closure Accessory Artefact Family.
P050006/S0385/28/14
HELEX Septal Occluder
W.L. Gore & Associates, Inc.Phoenix, AZ 85085
New supplier for biological indicators.
P050033/S0175/22/14
Hydrelle
Anika Therapeutics, IncorporatedBedford, MA 02110
Transfer of balance bread-and-butter absolution testing from S&N Laboratories to centralized testing at Anika Therapeutics.
P050037/S0485/7/14
Radiesse Dermal Filler
Merz North America, Inc.Franksville, WI 53126
Automation of the bushing action for the Radiesse product.
P050052/S0535/7/14
Radiesse Dermal Filler
Merz North America, Inc.Franksville, WI 53126
Automation of the bushing action for the Radiesse product.
P060006/S0595/1/14
Express SD Renal Monorail Premounted Stent System
Boston Scientific CorporationMaple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P060040/S0355/6/14
Thoratec HeartMate II Left Ventricular Assist Arrangement (LVAS)
Thoratec CorporationPleasanton, CA 94588
Addition of a supplier for the sintering action for the HeartMate II LVAS components.
P070015/S1235/13/14
XIENCE V® Everolimus Eluting Coronary Stent Systems
Abbott VascularTemecula, CA 92591
Addition of accepting analysis and testing activities of raw abstracts and accumulation items at the Clonmel, Ireland ability and arrangement laboratories.
P080012/S0205/22/14
Prometra Programmable Infusion Pump System
Flowonix Medical, Inc.Mount Olive, NJ 07828
Alternate Electronic Modules Random Admission Memory (RAM).
P080020/S0075/30/14
Gel-One
Seikagaku CorporationTokyo, Japan100-0005
Addition of two new raw actual accumulator rooms.
P090013/S1405/15/14
Revo MRI IPG
Medtronic CRDMMounds View, MN 55112
Antenna wire band covering accomplishment acclimation for the devices.
P090013/S1415/29/14
REVO MRI Implantable Beating Generators (IPG)
Medtronic, Inc.Mounds View, MN 55112
Changes to the aperture analysis system.
P090013/S1425/28/14
CapSureFix MRI Lead
Medtronic CRDMMounds View MN, 55112
Tip acid action advance for braid components.
P100021/S0345/6/14
Endurant Stent Graft System
Medtronic VascularSanta Rosa, CA 95403
Change to the sterilization amount configuration.
P100021/S0375/23/14
Endurant Stent Graft System
Medtronic VascularSanta Rosa, CA 95403
Relocation of a added bank supplier of a analytical component.
P100023/S0945/1/14
ION (Taxus Element) Coronary Stent System
Boston Scientific CorporationMaple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P100023/S0955/1/14
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent Arrangement Monorail and Over-the-Wire
Boston Scientific CorporationMaple Grove, MN 55311
Change to the stent analysis requirements.
P100023/S0975/22/14
ION™ Paclitaxel- Eluting Coronary Stent Arrangement (Monorail and Over-The-Wire Systems)
Boston Scientific CorporationMaple Grove, MN 55311
Change to use a blush camera for the distal tip analysis process.
P100026/S0165/1/14
Neuropace RNS System
NeuroPace, Inc.Mountain View, CA 94043
Add alternating equipment.
P100040/S0195/6/14
Valiant Stent Graft with the Captivia Delivery System
Medtronic VascularSanta Rosa, CA 95403
Change to the sterilization amount configuration.
P100041/S0525/1/14
Edwards SAPIEN® Transcatheter Heart Valve
Edwards Lifesciences, LLCIrvine, CA 92614
Addition of an alternating tissue supplier.
P100041/S0535/16/14
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories
Edwards Lifesciences, LLCIrvine, CA 92614
Changes to the accomplishment accessories acclimated in the accomplishment of the RetroFlex 3 Delivery System.
P100044/S0165/23/14
Propel and Propel Mini Sinus Implants
Intersect ENTMenlo Park, CA 94025
Addition of a new accessory sealing equipment, Sencorp White Heat Sealer with Vaccuum and Gas Purge Model 12-PV/2, to the absolute accomplishment band for the packaging of the Propel and Propel Mini Sinus Implants.
P110002/S0065/2/14
LDR SpineMobi-C® Cervical Disc Prosthesis for use at One or Two Levels
LDR Spine USA, Inc.Austin, TX 78750
Modifications to several final inspections.
P110004/S0035/12/14
NIRxcell CoCr Coronary Stent on RX System
Medinol Ltd.Tel Aviv, Israel61581
Addition of a new apple-pie allowance to the Medinol Jerusalem accomplishment plant.
P110009/S0065/2/14
LDR Spine Mobi-C® Cervical Disc Prosthesis for use at One or Two Levels
LDR Spine USA, Inc.Austin, TX 78750
Modifications to several final inspections.
P110010/S0795/1/14
PROMUS Aspect Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P110010/S0805/1/14
PROMUS Aspect Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent Arrangement Monorail and Over-the-Wire
Boston Scientific CorporationMaple Grove MN 55311
Change to the stent analysis requirements.
P110010/S0825/12/14
PROMUS Element™ Plus/Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System
Boston Scientific CorporationMaple Grove, MN 55311
Upgrade to the accepted Chip Crimp and Cone Puff (ICCP) machines such that functionalities associated with the Non-Contact Altitude Arrangement (NCMS) will be accumulated with the ICCP on one machine.
P110010/S0845/22/14
PROMUS® Element™ Plus Everolimus-Eluting Coronary Stent System
Boston Scientific CorporationMaple Grove, MN 55311
Change to use a blush camera for the distal tip analysis process.
P110013/S0395/2/14
Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Medtronic Inc.Santa Rosa, CA 95403
Upgrade to the Wire Forming apparatus that is currently acclimated on Integrity stents.
P110013/S0405/23/14
Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Medtronic VascularSanta Rosa, CA 95403
Change to the stent sub-assembly accomplishment equipment.
P110019/S0675/13/14
XIENCE PRIME®/XIENCE Xpedition® Everolimus ElutingCoronary Stent Systems
Abbott VascularTemecula, CA 92591
Addition of accepting analysis and testing activities of raw abstracts and accumulation items at the Clonmel, Ireland ability and arrangement laboratories.
P110021/S0395/1/14
Edwards SAPIEN® Transcatheter Heart Valve
Edwards Lifesciences, LLCIrvine, CA 92614
Addition of an alternating tissue supplier.
P110021/S0405/16/14
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories
Edwards Lifesciences, LLCIrvine, CA 92614
Changes to the accomplishment accessories acclimated in the accomplishment of the RetroFlex 3 Delivery System.
P110035/S0255/14/14
Epic Vascular Self-Expanding Stent System
Boston Scientific Corp.Maple Grove, MN 55311
Changes to the ethylene oxide sterilization process.
P110035/S0275/23/14
Epic Vascular Self-Expanding Stent System
Boston Scientific Corp.Maple Grove, MN 55311
Relocation of the accomplishment for the E-tube basic from one Boston Scientific Corporation ability to another.
P110042/S0335/28/14
Subcutaneous Implantable Defibrillator (S-ICD) System
Cameron Health, Inc.San Clemente, CA 92673
Transfer the final amalgamation for the EIT from Cameron to Cameron’s arrangement architect Boston Scientific Corporation (BSC).
P110042/S0345/29/14
Subcutaneous Implantable Defibrillator (S-ICD) System
Cameron Health, Inc.San Clemente, CA 92673
Add a dropout voltage aberration analysis in the accomplishment action for the S-ICD beating generator.
P110042/S0355/30/14
SQ-RX Beating Generator
Boston Scientific CRMSt. Paul, MN 55112
Changes accompanying to accomplishment action of the array including condoning a new band machine, modifying the careful band acclimated in shipping, and new fixtures.
P110043/S0065/13/14
Omnilink Elite® Vascular Stent Systems
Abbott VascularTemecula, CA 92591
Addition of accepting analysis and testing activities of raw abstracts and accumulation items at the Clonmel, Ireland ability and arrangement laboratories.
P120002/S0035/12/14
SMART Ascendancy Vascular Stent Systems
Cordis CorporationFremont, CA 94555
Change in accomplishment ability for the supplier of the slider accumulation and handle and the accession of a new abstraction machine.
P120005/S0175/2/14
Dexcom G4 PLATINUM Continuous Glucose Ecology System
Dexcom, Inc.San Diego, CA 92121
Change for the adjustment of altitude of analytical ambit during accepting analysis of the Dexcom G4 PLATINUM transmitter tray, and the use of a aliment brand silicone aerosol during accomplishment of the transmitter tray.
P120010/S0205/8/14
MiniMed 530G System
Medtronic MiniMedNorthridge, CA 91325
Change to the laser acid affairs ambit of the Resonetics Galvo Laser System.
P120010/S0225/14/14
MiniMed 530G System
Medtronic MiniMedNorthridge, CA 91325
Addition of an automatic charwoman arrangement for apparatus acclimated in the Enlite Sensor, which is a basic of the MiniMed 530G System.
P130006/S0035/28/14
VIABAHN Endoprosthesis
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W.L. Gore & Associates, Inc.Phoenix, AZ 85085
New supplier for biological indicators.
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