N970003/S1527/25/13Real-Time
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Advantio, Ingenio, Vitalio, Formio ancestors of Implantable Pulse Generators, Application Software
Boston Scientific Corporation St. Paul, MN 55112
Approval for Model 2869 ZOOMVIEW Programmer Software Appliance v1.09 and Ingenio Firmware adaptation D_v1.02 with Patch v1.01 for the devices.
P790007/S0377/31/13135-Day
Hancock® Adapted Orifice Valved Conduit
Medtronic Heart ValvesSanta Ana, CA 92705
Approval to use two new autoclaves.
P810032/S0637/23/13180-Day
PMMA Multi-Piece Posterior Chamber Intraocular Lenses (IOLs)
Alcon Research, Ltd.Fort Worth, TX 76134
Approval for a accomplishment armpit amid at Alcon Research, Ltd., in Lesage, West Virginia.
P830061/S0937/23/13Real-Time
Adhesive, CapSure Lead, Vitatron Crystalline Lead, Vitatron Excellence PS Lead
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P840060/S0397/23/13180-Day
PMMA Single-PiecePosterior Chamber IOLs
Alcon Research, Ltd.Fort Worth, TX 76134
Approval for a accomplishment armpit amid at Alcon Research, Ltd., in Lesage, West Virginia.
P850089/S0987/23/13Real-Time
CapSure SP Novus, CapSure SP Z, CapSure Z Novus, Impulse II Leads
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P870078/S0207/31/13135-Day
Hancock® Porcine Bioprosthesis
Medtronic Heart ValvesSanta Ana, CA 92705
Approval to use two new autoclaves.
P880087/S0217/23/13180-Day
PMMA Anterior Chamber IOLs
Alcon Research, Ltd.Fort Worth, TX 76134
Approval for a accomplishment armpit amid at Alcon Research, Ltd., in Lesage, West Virginia.
P890003/S2777/15/13Real-Time
Synergyst II Pacing System, CareLink Monitors, CareLink Express Monitors, CardioSight Readers
Medtronic, Inc. Mounds View, MN 55112
Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.
P890003/S2787/23/13Real-Time
Synergyst II Pacing System, CapSure Lead, Prodigy IPG, Service Kit-Pacemaker Repair Kit
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P900061/S1227/23/13Real-Time
7216A PCD
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P910073/S1187/16/13Real-Time
ENDOTAK Lead System
Boston ScientificSt. Paul, MN 55112
Approval for an alternating album actual for the Acquiescent FixationReliance IS-1/4-SITE leads.
P920015/S1137/23/13Real-Time
Transvene, SQ, Sprint and Sprint Fidelis Lead Models and Accessories
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P920047/S0587/22/13135-Day
EPT-1000 Cardiac Ablation System
Boston Scientific Corp.San Jose, CA 95134
Approval to move the banishment action for Blazer Prime AblationCatheters to a new accomplishment band introducing an automatic action to analyze and cutmarked sections of the extruded shaft.
P930014/S0667/23/13180-Day
AcrySof IOLs
Alcon Research, Ltd.Fort Worth, TX 76134
Approval for a accomplishment armpit amid at Alcon Research, Ltd., in Lesage, West Virginia.
P930021/S0137/2/13180-Day
Straumann Emdogain
Straumann USAAndover, MA 01810
Approval for a accomplishment armpit amid at Medeon Science Park, in Malmo, Sweden.
P930039/S0897/23/13Real-Time
CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, Torque Clip Device, Vitatron Crystalline Lead
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P940035/S0107/16/13Special
NMP22 Analysis Kit (EIA), NMP22 Urine Accumulating KitNMP22, Bladder-Chek Test
Alere Scarborough, Inc.Scarborough, ME 04074
Approval for additions to the Limitations and Precautions sections of the Package Insert.
P950005/S0427/22/13135-Day
Celsius, Celsius RMT, EZ Steer Non-Temp Sensing Ablation Catheters
Biosense Webster, Inc. Diamond Bar, CA 91765
Approval for the alteration of the Grinding Action from Irwindale, California accomplishment ability to Juarez, Mexico accomplishment facility.
P950008/S0107/15/13Special
Silikon™ 1000 (Purified polydimethyl-siloxane)
Alcon Laboratories, Incorporated Fort Worth, TX 76134
Approval for labeling modifications to the Silikon™ 1000 Oil Directions for Use.
P950018/S0167/9/13180-Day
PERFLUORON™ Ocular Endotamponade
Alcon Laboratories, Inc. Fort Worth, TX 76134
Approval for changes to the adhering resins (limonene-based adhering TR7125 has replaced the accepted limonene-based adhering TR1135, and ethylene vinyl acetate adhering UL8705 has replaced the accepted EVA adhering 205W) acclimated for the Tyvek lid and validation of an air-over-steam (AOS) sterilization aeon to adjust practices amid articles aural the accomplishment facility.
P950024/S0507/23/13Real-Time
CapSure Epicardial Pacing Lead
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P950032/S0727/11/13Real-Time
Apligraf (Graftskin)
Organogenesis, Inc.Canton, MA02021
Approval for the accession of Animal Epidermal Keratinocyte cellstrain 197 (HEP 197) for use in the accomplish of Apligraf, and for approval of a change from the accepted analysis appraisal for apprehension of assertive viral contaminants to a real-time PCR adjustment from a accepted gel-based PCR method.
P950037/S1247/12/13Real-Time
Dromos DR/SR Rate Adaptive Pacing Systems
Biotronik, Inc.6024 Jean Road Lake Oswego, OR 97035
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Approval of the accession of a pacing arrangement analyzer (PSA)module to the Renamic Programmer, as able-bodied as an adapted affectation awning and associatedlabeling updates.
P950037/S1257/30/13Real-Time
Dromos DR/SR Rate Adaptive Pacing Systems
Biotronik, Inc. Lake Oswego, OR 97035
Approval for an alternating separator actual acclimated in the Litronik batteries for the devices.
P960016/S0427/18/13135-Day
Livewire Cardiac Ablation System
St. Jude MedicalMinnetonka, MN 55345
Approval to amend the action ambit in the accomplishment action for a new bang mold.
P970003/S1627/10/13Real-Time
VNS Therapy System
Cyberonics, Inc.Houston, TX 77058
Approval for a change to the Transmit to Receive Refractory Timewhich is a blueprint of the Appliance Specific Integrated Circuit (ASIC) acclimated in Model103/104/105 VNS Generators and the accomplishing of a screening analysis to be performed at thevendor (ON Semiconductor).
P970031/S0417/31/13135-Day
Freestyle® Aortic Root Bioprosthesis
Medtronic Heart ValvesSanta Ana, CA 92705
Approval to use two new autoclaves.
P980016/S4167/15/13Real-Time
Medtronic Implantable Cardioverter Defibrillator Families (GEM, Marquis, Maximo,Intrinsic Onyx, EnTrust, Virtuoso, Secura, Protecta) and Model 6940 CapSureFix Lead
Medtronic, Inc. Mounds View, MN 55112
Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.
P980016/S4177/23/13Real-Time
Medtronic Implantable Cardioverter Defibrillator Families (GEM, Marquis, Maximo,Intrinsic Onyx, EnTrust, Virtuoso, Secura, Protecta) and Model 6940 CapSureFix Lead
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P980022/S1347/8/13Real-Time
Paradigm REAL-Time Revel System
Medtronic MiniMedNorthridge, CA 91325
Approval for software changes to the Paradigm REAL-Time RevelInsulin Pump (MMT-523, MMT-523K, MMT-723, and MMT-723K) appliance software. TheParadigm REAL-Time Revel Insulin Pump is a basic of the Paradigm REAL-Time RevelSystem.
P980023/S0567/30/13Real-Time
Phylax lCD System
Biotronik, Inc.Lake Oswego, OR 97035
Approval for the accessory labeling modifications/corrections, whichincludes an amend of the Indication for Use Statements (IFU) to accommodate the bazaar approveddevices with the aforementioned IFU, and added accessory corrections to the labeling.
P980035/S3257/15/13Real-Time
Kappa 700/600 Series of Pulse Generators, Advisa, EnRhythm MRI,
Medtronic, Inc. Mounds View, MN 55112
Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.
P980035/S3267/17/13Real-Time
Adapta, Versa, Sensia, Relia Implantable Pulse Generators
Medtronic, Inc. Mounds View, MN 55112
Approval for a architecture change to the L386 Integrated Circuit and associated accessory accomplishment changes.
P980035/S3277/23/13Real-Time
Kappa 700/600 Series of Pulse Generators, Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Relia Implantable Pulse Generators (IPGs)
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P980043/S0417/31/13135-Day
Hancock® II Bioprosthetic Heart Valve
Medtronic Heart ValvesSanta Ana, CA 92705
Approval to use two new autoclaves.
P980050/S0847/23/13Real-Time
Transvene Lead
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P990001/S1127/23/13Real-Time
Vitatron C20 SR, Vitatron C60 DR, Vitatron T20 SR, Vitatron T60 DR IPGs
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P990025/S0357/22/13135-Day
NaviStar, NaviStar RMT, EZ Steer Nay Catheters and BW Cables
Biosense Webster, Inc. Diamond Bar, CA 91765
Approval for the alteration of the Grinding Action from Irwindale, California accomplishment ability to Juarez, Mexico accomplishment facility.
P990046/S0347/30/13Special
Open Pivot Heart Valve and Open Pivot Aortic Valved Graft
Medtronic, Inc. Minneapolis, MN 55432
Approval for alteration the account of abeyant adverse contest in the Instructions for Use.
P990064/S0497/31/13135-Day
Mosaic® Porcine Bioprosthesis
Medtronic Heart ValvesSanta Ana, CA 92705
Approval to use two new autoclaves.
P990071/S0237/17/13Real-Time
SMARTA-BLATE™ Arrangement and SMARTA-BLATE™ Irrigation Pump kit
Biosense Webster, Inc. Diamond Bar, CA 91765
Approval for a accessory software amend for SMARTA-BLATE™ Irrigation Pump from Adaptation 1.2 to 1.3.
P990081/S0177/23/13Real-Time
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc. Tucson, AZ 85755
Approval for modifications in architecture to anticipate decay arrangement overflow or added leaks from causing shorting altitude with the BenchMark ULTRA’s centralized circuits.
P990081/S0197/25/13Real-Time
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc. Tucson, AZ 85755
Approval for accessory modifications to the architecture of the dispenser inwhich the PMA reagents in the accessories are stored and or used, including a change in the materialsthe assorted dispenser genitalia are fabricated from.
P000039/S0497/26/13135-Day
AMPLATZER™ Septal Occluder and AMPLATZER™ Multi-Fenestrated Septal Occluder – “Cribiform”
AGA Medical Corporation Plymouth, MN 55442
Approval for an alternating antecedent of accepted bioburden and sterility testing, as able-bodied as changes to the bioburden testing protocol.
P000040/S0287/9/13Real-Time
Genesys HTA System
Boston Scientific Corporation Marlborough, MA 01752
Approval for an activity directed adjustment action for the Genesys HTA clarify accumulation components.
P000040/S0307/19/13Real-Time
Genesys HTA System
Boston Scientific Corporation Marlborough, MA 01752
Approval for a change to the gold array blueprint of the cassette acquaintance pins from “flash gold” to ≥ 15 μ-inches and a modification to the agent tray so that the acquaintance pins do not acquaintance its lid.
P010014/S0447/30/13Special
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Oxford® Partial Knee System
Biomet Accomplishment Corporation Warsaw, IN 46581
Approval for changes to the surgical address manual.
P010015/S2017/15/13Real-Time
Attain, Consulta, InSync, Syncra Cardiac Resynchronization Therapy- Pacemaker (CRT-Ps)
Medtronic, Inc. Mounds View, MN 55112
Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.
P010015/S2027/23/13Real-Time
Attain, Consulta, InSync, Syncra Cardiac Resynchronization Therapy- Pacemaker (CRT-Ps)
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P010030/S0427/22/13180-Day
LifeVest Wearable Defibrillator
ZOLL LifeCor Corporation Pittsburgh, PA 15238
Approval for software enhancements to the WCD 4000 LifeVest® Wearable Defibrillator and the consecutive affectation of that advice on the defended LifeVest.
P010031/S3767/15/13Real-Time
Concerto, Concerto CRT-D, Concerto II CRT-D, Consulta CRT-D, InSync II Marquis, InSync II Protect, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Consulta, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Brava CRT-D, Viva S CRT-D, Viva XT CRT-D
Medtronic, Inc. Mounds View, MN 55112
Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.
P010031/S3777/23/13Real-Time
Concerto, Concerto CRT-D, Concerto II CRT-D, Consulta CRT-D, InSync II Marquis, InSync II Protect, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Consulta, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Brava CRT-D, Viva S CRT-D, Viva XT CRT-D
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P010047/S0257/15/13180-Day
NeoMend ProGel Pleural Air Aperture Sealant
NeoMend, IncorporatedIrvine, CA 92618
Approval for a change in the aircraft temperature ambit to 1 °C to 30°C to acquiesce for abrupt accessible extremes in temperature during shipment. The Agency addendum that the "KeepRefrigerated" Label, C-00473, will to be added to the aircraft container.
P010047/S0267/25/13180-Day
NeoMend ProGel Pleural Air Aperture Sealant
NeoMend, IncorporatedIrvine, CA 92618
Approval for a change in the aircraft temperature ambit to 1ºC to 30°C to allowfor abrupt accessible extremes in temperature during shipment. The Agency addendum that the "KeepRefrigerated" Label, C-00473, will be added to the aircraft container.
P010068/S0327/22/13135-Day
Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS Catheters
Biosense Webster, Inc. Diamond Bar, CA 91765
Approval for the alteration of the Grinding Action from Irwindale, California accomplishment ability to Juarez, Mexico accomplishment facility.
P020024/S0397/26/13135-Day
AMPLATZER™ Duct Occluder
AGA Medical Corporation Plymouth, MN 55442
Approval for an alternating antecedent of accepted bioburden and sterility testing, as able-bodied as changes to the bioburden testing protocol.
P020055/S0087/25/13Real-Time
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc. Tucson, AZ 85755
Approval for accessory modifications to the architecture of the dispenser inwhich the PMA reagents in the accessories are stored and or used, including a change in the materialsthe assorted dispenser genitalia are fabricated from.
P030005/S0997/25/13Real-Time
Invive, Intua ancestors of Cardiac Resynchronization Therapy Pacemakers (CRT-P), Application Software v1.09
Boston Scientific Corporation St. Paul, MN 55112
Approval for Model 2869 ZOOMVIEW Programmer Software Appliance v1.09 and Ingenio Firmware adaptation D_v1.02 with Patch v1.01 for the devices.
P030031/S0507/22/13135-Day
Celsius ThermoCool, Celsius RMT ThermoCool Catheters
Biosense Webster, Inc. Diamond Bar, CA 91765
Approval for the alteration of the Grinding Action from Irwindale, California accomplishment ability to Juarez, Mexico accomplishment facility.
P030036/S0587/23/13Real-Time
SelectSecure Lead
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P040020/S0457/23/13180-Day
AcrySof ReSTOR Apodized Diffractive IOLs
Alcon Research, Ltd.Fort Worth, TX 76134
Approval for a accomplishment armpit amid at Alcon Research, Ltd., in Lesage, West Virginia.
P040036/S0337/22/13135-Day
NaviStar ThermoCool, Navistar RMT Thermocool, EZ Steer ThermoCool Catheters
Biosense Webster, Inc. Diamond Bar, CA 91765
Approval for the alteration of the Grinding Action from Irwindale, California accomplishment ability to Juarez, Mexico accomplishment facility.
P040040/S0237/26/13135-Day
AMPLATZER™ Muscular VSD Occluder
AGA Medical Corporation Plymouth, MN 55442
Approval for an alternating antecedent of accepted bioburden and sterility testing, as able-bodied as changes to the bioburden testing protocol.
P040044/S0457/22/13180-Day
Mynx Vascular Closure Device
AccessClosure, Inc.Santa Clara, California 95054
Approval for a accomplishment armpit amid in Santa Clara, California.
P050006/S0357/17/13Special
Gore Helex Septal Occluder
W.L. Gore & AssociatesFlagstaff, AZ 86001
Approval to amend the absolute Gore Helex Septal Occluder Instructions forUse.
P050023/S0667/30/13Real-Time
Lumax Ancestors of ICD Accessories and CRT-D Devices
Biotronik, Inc. Lake Oswego, OR 97035
Approval for an alternating separator actual acclimated in the Litronik batteries for the devices.
P050023/S0677/30/13Real-Time
Ilesto 7 VR-T, Iforia 7 VR-T, Ilesto 5 VR-T, Iforia 5 VR-T, Lumax 700 VR-T, Lumax 600VR-T, Lumax 740 VR-T, Lumax 640 VR-T, Ilesto 7 VR-T DX, Iforia 7 VR-T DX, Ilesto 5VR-T DX, Iforia 5 VR-T DX, Lumax 740 VR-T DX, Lumax 640 VR-T DX, Ilesto 7 DRT,Iforia 7 DR-T, Ilesto 5 DR-T, Iforia 5 DR-T, Lumax 700 DR-T, Lumax 600 DR-T, Lumax 740 DR-T, Lumax 640 DR-T, Ilesto 7 HF-T, Iforia 7 HF-T, Ilesto 5 HF-T, Iforia 5 HF-T, Lumax 700 HF-T, Lumax 600 HF-T, Lumax 740 HF-T, Lumax 640 HF-T
Biotronik, Inc.Lake Oswego, OR 97035
Approval for the accessory labeling modifications/corrections, whichincludes an amend of the Indication for Use Statements (IFU) to accommodate the bazaar approveddevices with the aforementioned IFU, and added accessory corrections to the labeling.
P060022/S0167/1/13Real-Time
Akreos AO60 Intraocular Lens (IOL)
Bausch & Lomb Incorporated Aliso Viejo, CA 92656
Approval for a labeling change to accommodate the accession of a new intraocular lens (IOL) inserter, INJ100, in the Directions for Use.
P060039/S0477/23/13Real-Time
Attain StarFix Lead
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P070008/S0447/30/13Real-Time
Entovis HF(-T), Evia HF(-T) Ancestors of CRT-P Devices
Biotronik, Inc. Lake Oswego, OR 97035
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Approval for an alternating separator actual acclimated in the Litronik batteries for the devices.
P070026/S0087/17/13Real-Time
DePuy Ceramax Bowl absolute Hip System
Depuy, Inc. Warsaw, IN 46581
Approval for the accession of Summit Porocoat Stems as a accordant basic to the absolute 28mm bowl head.
P070026/S0147/2/13180-Day
CERAMAX® Bowl Absolute Hip System
Depuy, Inc. Warsaw, IN 46581
Approval of the post-approval abstraction protocol.
P080004/S0117/10/13180-Day
iSert® Preloaded Posterior Chamber Intraocular Lens
Hoya Surgical Optics Chico Hills, CA 91709
Approval for the iSert® Model 251 Preloaded Posterior Chamber Intraocular Lens (IOL) and iSert® Model 250 Preloaded Posterior Chamber IOL.
P080006/S0547/23/13Real-Time
Attain Ability Lead
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P080011/S0247/16/13180-Day
CooperVision comfilcon A Soft (Hydrophilic) Extended Wear Acquaintance Lenses
CooperVision™, Incorporated Pleasanton, CA 94588
Approval to add the new cast name Biofinity XR.
P080012/S0167/2/13Real-Time
Prometra Programmable Implantable Pump
Flowonix Medical, Incorporated Mount Olive, NJ 07828
Approval for the accession of an alternating sub-tier supplier and actual change for the molded silicone cannula ache abatement and clarify seal, which are both apparatus of the implantable pump.
P080032/S0127/3/13180-Day
Alair Bronchial Thermoplasty System
Boston Scientific CorporationMarlborough, MA 01752
Approval for 1) the accomplishment alteration of the Alair Catheter from the accepted ability in Sunnyvale, California, to the Boston Scientific ability in Cork, Ireland; and 2) thequalification of Synergy Health Ireland Ltd, amid in Tullamore, Ireland, as a sterilization sitefor the Alair Catheter, and accessory architecture changes to the Alair Catheter.
P090013/S0987/15/13Real-Time
Revo MRI
Medtronic, Inc. Mounds View, MN 55112
Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.
P090013/S0997/23/13Real-Time
CapSureFix MRI Lead, Revo MRI IPG
Medtronic, Inc. Mounds View, MN 55112
Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.
P090022/S0177/25/13Real-Time
Softec HD™, Softec HD™ PS, Softec HDO™ and Softec I™ Posterior Chamber Intraocular Lenses (IOLs)
Lenstec, Inc. St. Petersburg, FL 33716
Approval for a altered commitment system, the accessory which holds the intraocular lens (IOL) in abode aural its acrid abounding vial.
P100010/S0307/26/13Real-Time
Arctic Front Cardiac CryoAblation Catheters, Arctic Front Advance Cardiac CryoAblation Catheters
Medtronic CryoCath LP Marie Kirkland, Quebec, CanadaH9H 5H3
Approval for the abatement of the alien aperture apprehension wire and associated inductor.
P100022/S0067/19/13Special
Zilver PTX Drug-Eluting Peripheral Stent (6 – 8 mm diameter; 20 – 120 mm length)
Cook, Inc. Bloomington, IN 47402
Approval for modifications to the Instructions For Use (IFU) to advance accuracy by accouterment recommendations for adapted guidewire alternative and added instructions for back attrition is encountered during catheter use.
P100027/S0077/22/13Real-Time
INFORM HER2 Dual ISH DNA Probe
Ventana Medical Systems, Inc. Tucson, AZ 85755
Approval for modifications in architecture to anticipate decay arrangement overflow or added leaks from causing shorting altitude with the BenchMark ULTRA’s centralized circuits.
P100027/S0097/25/13Real-Time
INFORM HER2 Dual ISH DNA Probe
Ventana Medical Systems, Inc. Tucson, AZ 85755
Approval for accessory modifications to the architecture of the dispenser inwhich the PMA reagents in the accessories are stored and or used, including a change in the materialsthe assorted dispenser genitalia are fabricated from.
P100042/S0017/15/13180-Day
APTIMA® HPV Assay
Gen-Probe Incorporated San Diego, CA 92121
Approval for the accession of the PANTHER Arrangement to the APTIMA® HPV Assay. The device, as modified, will be marketed beneath the barter name APTIMA® HPV Assay. The APTIMA HPV Appraisal is an in vitro nucleic acerbic addition analysis for the qualitative apprehension of E6/E7 viral agent RNA (mRNA) from 14 high-risk types of animal papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the appraisal include: 16, 18, 31, 33, 35, 39, 45, 51, 52,56, 58, 59, 66, and 68. The APTIMA HPV Appraisal does not discriminate amid the 14 high-risk types. Cervical specimens calm in ThinPrep Pap Analysis vials absolute PresesrvCyt Solution and calm with broom-type or cytobrush/spatula accumulating devices* may be activated with the APTIMA HPV Assay. The appraisal is acclimated with the TIGRIS DTS Arrangement or the PANTHER System. The use of the analysis is indicated: 1) To awning women 21 years and earlier with aberant squamous beef of undetermined acceptation (ASC-US) cervical analysis after-effects to actuate the charge for barometer to colposcopy. The after-effects of this analysis are not advised to anticipate women from proceeding to colposcopy; and 2) In women 30 years and older, the APTIMA HPV Appraisal can be acclimated with cervical analysis to adjunctively awning to appraise the attendance or absence of high-risk HPV types. This information, calm with the physician’s appraisal of analysis history, added accident factors, and able guidelines, may be acclimated to adviser accommodating management. *Broom-type accessory (e.g., Wallach Pipette) or endocervical brush/spatula.
P100044/S0087/17/13180-Day
Propel™ Mini Sinus Implant
Intersect ENT Menlo Park, CA 94025
Revise the adherence agreement to reflect the biologic absolution accepting belief of ± 12% of the ambition amount acclimated for artefact release.
P100047/S0227/3/13Special
HeartWare Ventricular Assist System
HeartWare, Inc. Miami Lakes, FL 33014
Approval for updates to the Instructions for Use and Accommodating Chiral of the accessory to accommodate warnings and advice accompanying to electrostatic acquittal acknowledgment and exchanging ability sources.
P110010/S0507/15/13135-Day
PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent Arrangement (Monorail® and Over-The-Wire)
Boston Scientific Corporation Maple Grove, MN 55311
Approval for an advancement to an analysis arrangement camera and software.
P110013/S0177/2/13180-Day
Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Medtronic Vascular Santa Rosa, CA 95403
Approval for an adapted Annual Adherence agreement to bracket the added 34 mm and 38 mm breadth stent sizes.
P110016/S0037/30/13180-Day
Cool Path Duo Ablation Catheter, MediGuide Enabled and Safire Duo Ablation Catheter, MediGuide Enabled
St. Jude Medical Minnetonka, MN 55345
Approval for adding a MediGuide Technology acquiescent sensor into the tip of the accessory for the purposes of acceptable aeronautics and changing the Cool Path Duo Uni-Directional (Uni-D) handle to a Cool Path Duo Bi-Directional (Bi-D) handle. The devices, as modified, will be marketed beneath the barter names Cool Path™ Duo Ablation Catheter, MediGuide Enabled™ and Safire™ Duo Ablation Catheter, MediGuide Enabled™ and are adumbrated for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the analysis of archetypal atrial flutter. The catheters are advised for use with a accordant alien pump and the IBI-1500T9-CP RF Generator at a best of 50 watts. MediGuide Enabled™ Ablation Catheters are acclimated with the MediGuide™ Technology to accredit real-time tip accession and navigation. The MediGuide™ Technology is adumbrated for use as an accessory to fluoroscopy.
P110019/S0437/15/13Real-Time
XIENCE Xpedition™ Everoliums Eluting Coronary Stent System, XIENCE Xpedition™ LL Everolimus Eluting Coronary Stent, System, XIENCE Xpedition™ SV Everolimus Eluting Coronary Stent System
Abbott Vascular Temecula, CA 92591
Approval to amend the labeling for the Xience Xpedition, Xience Xpedition SV, and Xience Xpedition LL Everolimus Eluting Coronary Stent Rapid Exchange (RX) Arrangement to reflect a 24-month shelf life.
P110019/S0457/26/13180-Day
XIENCE PRIME Stent Systems
Abbott Vascular Temecula, CA 92591
Approval of the post-approval abstraction protocol.
P110021/S0047/2/13180-Day
Edwards SAPIENTM Transcatheter Heart Valve with RetroFlex 3 Commitment Arrangement Edwards SAPIENTMTranscatheter Heart Valve with Ascendra Commitment Arrangement and accessories (RetroFlexTm Balloon Catheter, AscendraM Balloon Aortic Valvuloplasty Catheter, Ascendram Administrator Sheath Set;and Crimper
Edwards Lifesciences, LLCIrvine, CA 92614
Approval for architecture modifications to the Ascendra Balloon Catheter, Models9100BCL23 (23mm) and 9100BCL26 (26mm), and the Ascendra Administrator Sheath Set, Model91001S. The device, as modified, will bemarketed beneath the barter name Ascendra 3 Commitment System, Models 9120AS23 (23mm) and 9120AS26 (26mm) and Ascendra 3 Administrator Sheath Set, Model 9120IS (26F) and is indicatedfor the transapical commitment of the Edwards SAPIEN Transcatheter Heart Valve (delivery system)and for the accession and abatement of accessories acclimated with the Edwards SAPIEN TranscatheterHeart Valve (introducer sheath set).
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