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U.S. Department of Health and Human Services

Medical Devices

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July 2013 PMA Approvals

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS

P120022
7/12/13

therascreen® EGFR RGQ PCR Kit

QIAGEN Manchester Ltd
Manchester,
United Kingdom
M 15 6SH

Approval for the therascreen® EGFR RGQ PCR Kit. This device is indicated for:
The therascreen® EGFR RGQ PCR Kit is a real-time PCR test for the qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPE) nonsmall
cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to select patients
with NSCLC for whom GILOTRIF™ (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is
indicated. Safety and efficacy of GILOTRIF™ (afatinib) have not been established in patients whose tumors have L861Q, G719X, 87681, exon 20 insertions, and T790M mutations, which
are also detected by the therascreen® EGFR RGQ PCR Kit.  Specimens are processed using the QIAamp® DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene® Q MDx instrument for automated amplification and
detection.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS

N970003/S152
7/25/13
Real-Time

Advantio, Ingenio, Vitalio, Formio family of Implantable Pulse Generators,
Application Software

Boston Scientific Corporation
St. Paul, MN
55112

Approval for Model 2869 ZOOMVIEW Programmer Software Application v1.09 and Ingenio Firmware version D_v1.02 with Patch v1.01 for the devices.

P790007/S037
7/31/13
135-Day

Hancock® Modified Orifice Valved Conduit

Medtronic Heart Valves
Santa Ana, CA
92705

Approval to use two new autoclaves.

P810032/S063
7/23/13
180-Day

PMMA Multi-Piece Posterior Chamber Intraocular Lenses (IOLs)

Alcon Research, Ltd.
Fort Worth, TX 76134

Approval for a manufacturing site located at Alcon Research, Ltd., in Lesage, West Virginia.

P830061/S093
7/23/13
Real-Time

Adhesive, CapSure Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P840060/S039
7/23/13
180-Day

PMMA Single-Piece
Posterior Chamber IOLs

Alcon Research, Ltd.
Fort Worth, TX 76134

Approval for a manufacturing site located at Alcon Research, Ltd., in Lesage, West Virginia.

P850089/S098
7/23/13
Real-Time

CapSure SP Novus, CapSure SP Z, CapSure Z Novus, Impulse II Leads

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P870078/S020
7/31/13
135-Day

Hancock® Porcine Bioprosthesis

Medtronic Heart Valves
Santa Ana, CA
92705

Approval to use two new autoclaves.

P880087/S021
7/23/13
180-Day

PMMA Anterior Chamber IOLs

Alcon Research, Ltd.
Fort Worth, TX 76134

Approval for a manufacturing site located at Alcon Research, Ltd., in Lesage, West Virginia.

P890003/S277
7/15/13
Real-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/S278
7/23/13
Real-Time

Synergyst II Pacing System, CapSure Lead, Prodigy IPG, Service Kit-Pacemaker Repair Kit

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P900061/S122
7/23/13
Real-Time

7216A PCD

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P910073/S118
7/16/13
Real-Time

ENDOTAK Lead System

Boston Scientific
St. Paul, MN
55112

Approval for an alternate primer material for the Passive Fixation
Reliance IS-1/4-SITE leads.

P920015/S113
7/23/13
Real-Time

Transvene, SQ, Sprint and Sprint Fidelis Lead Models and Accessories

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P920047/S058
7/22/13
135-Day

EPT-1000 Cardiac Ablation System

Boston Scientific Corp.
San Jose, CA
95134

Approval to move the extrusion process for Blazer Prime Ablation
Catheters to a new manufacturing line introducing an automated process to identify and cut
marked sections of the extruded shaft.

P930014/S066
7/23/13
180-Day

AcrySof IOLs

Alcon Research, Ltd.
Fort Worth, TX 76134

Approval for a manufacturing site located at Alcon Research, Ltd., in Lesage, West Virginia.

P930021/S013
7/2/13
180-Day

Straumann Emdogain

Straumann USA
Andover, MA
01810

Approval for a manufacturing site located at Medeon Science Park, in Malmo, Sweden.

P930039/S089
7/23/13
Real-Time

CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, Torque Clip Device, Vitatron Crystalline Lead

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P940035/S010
7/16/13
Special

NMP22 Test Kit (EIA), NMP22 Urine Collection Kit
NMP22, Bladder-Chek Test

Alere Scarborough, Inc.
Scarborough, ME 04074

Approval for additions to the Limitations and Precautions sections of the Package Insert.

P950005/S042
7/22/13
135-Day

Celsius, Celsius RMT, EZ Steer Non-Temp Sensing Ablation Catheters

Biosense Webster, Inc.
Diamond Bar, CA 91765

Approval for the transfer of the Grinding Process from Irwindale, California manufacturing facility to Juarez, Mexico manufacturing facility.

P950008/S010
7/15/13
Special

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/S016
7/9/13
180-Day

PERFLUORON™ Ocular Endotamponade

Alcon Laboratories, Inc.
Fort Worth, TX 76134

Approval for changes to the adhesive resins (limonene-based resin TR7125 has replaced the current limonene-based resin TR1135, and ethylene vinyl acetate resin UL8705 has replaced the current EVA resin 205W) used for the Tyvek lid and validation of an air-over-steam (AOS) sterilization cycle to align practices among products within the manufacturing facility.

P950024/S050
7/23/13
Real-Time

CapSure Epicardial Pacing Lead

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P950032/S072
7/11/13
Real-Time

Apligraf (Graftskin)

Organogenesis, Inc.
Canton, MA
02021

Approval for the introduction of Human Epidermal Keratinocyte cell
strain 197 (HEP 197) for use in the manufacture of Apligraf, and for approval of a change from the current test assay for detection of certain viral contaminants to a real-time PCR method from a conventional gel-based PCR method.

P950037/S124
7/12/13
Real-Time

Dromos DR/SR Rate Adaptive Pacing Systems

Biotronik, Inc.
6024 Jean Road
Lake Oswego, OR 97035

Approval of the introduction of a pacing system analyzer (PSA)
module to the Renamic Programmer, as well as an updated display screen and associated
labeling updates.

P950037/S125
7/30/13
Real-Time

Dromos DR/SR Rate Adaptive Pacing Systems

Biotronik, Inc.
Lake Oswego, OR 97035

Approval for an alternate separator material used in the Litronik batteries for the devices.

P960016/S042
7/18/13
135-Day

Livewire Cardiac Ablation System

St. Jude Medical
Minnetonka, MN 55345

Approval to update the process parameters in the manufacturing procedure for a new injection mold.

P970003/S162
7/10/13
Real-Time

VNS Therapy System

Cyberonics, Inc.
Houston, TX
77058

Approval for a change to the Transmit to Receive Refractory Time
which is a specification of the Application Specific Integrated Circuit (ASIC) used in Model
103/104/105 VNS Generators and the implementation of a screening test to be performed at the
vendor (ON Semiconductor).

P970031/S041
7/31/13
135-Day

Freestyle® Aortic Root Bioprosthesis

Medtronic Heart Valves
Santa Ana, CA
92705

Approval to use two new autoclaves.

P980016/S416
7/15/13
Real-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/S417
7/23/13
Real-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 increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P980022/S134
7/8/13
Real-Time

Paradigm REAL-Time Revel System

Medtronic MiniMed
Northridge, CA 91325

Approval for software changes to the Paradigm REAL-Time Revel
Insulin Pump (MMT-523, MMT-523K, MMT-723, and MMT-723K) application software. The
Paradigm REAL-Time Revel Insulin Pump is a component of the Paradigm REAL-Time Revel
System.

P980023/S056
7/30/13
Real-Time

Phylax lCD System

Biotronik, Inc.
Lake Oswego, OR 97035

Approval for the minor labeling modifications/
corrections, which
includes an update of the Indication for Use Statements (IFU) to include the market approved
devices with the same IFU, and other minor corrections to the labeling.

P980035/S325
7/15/13
Real-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/S326
7/17/13
Real-Time

Adapta, Versa, Sensia, Relia Implantable Pulse Generators

Medtronic, Inc.
Mounds View, MN 55112

Approval for a design change to the L386 Integrated Circuit and associated minor manufacturing changes.

P980035/S327
7/23/13
Real-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 increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P980043/S041
7/31/13
135-Day

Hancock® II Bioprosthetic Heart Valve

Medtronic Heart Valves
Santa Ana, CA
92705

Approval to use two new autoclaves.

P980050/S084
7/23/13
Real-Time

Transvene Lead

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P990001/S112
7/23/13
Real-Time

Vitatron C20 SR, Vitatron C60 DR, Vitatron T20 SR, Vitatron T60 DR IPGs

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P990025/S035
7/22/13
135-Day

NaviStar, NaviStar RMT, EZ Steer Nay Catheters and BW Cables

Biosense Webster, Inc.
Diamond Bar, CA 91765

Approval for the transfer of the Grinding Process from Irwindale, California manufacturing facility to Juarez, Mexico manufacturing facility.

P990046/S034
7/30/13
Special

Open Pivot Heart Valve and Open Pivot Aortic Valved Graft

Medtronic, Inc.
Minneapolis, MN 55432

Approval for revising the list of potential adverse events in the Instructions for Use.

P990064/S049
7/31/13
135-Day

Mosaic® Porcine Bioprosthesis

Medtronic Heart Valves
Santa Ana, CA
92705

Approval to use two new autoclaves.

P990071/S023
7/17/13
Real-Time

SMARTA-BLATE™ System and SMARTA-BLATE™ Irrigation Pump kit

Biosense Webster, Inc.
Diamond Bar, CA 91765

Approval for a minor software update for SMARTA-BLATE™ Irrigation
Pump from Version 1.2 to 1.3.

P990081/S017
7/23/13
Real-Time

PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems, Inc.
Tucson, AZ
85755

Approval for modifications in design to prevent waste system overflow or other leaks from causing shorting conditions with the BenchMark ULTRA’s internal circuits.

P990081/S019
7/25/13
Real-Time

PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems, Inc.
Tucson, AZ
85755

Approval for minor modifications to the design of the dispenser in
which the PMA reagents in the devices are stored and or used, including a change in the materials
the various dispenser parts are made from.

P000039/S049
7/26/13
135-Day

AMPLATZER™ Septal Occluder and AMPLATZER™ Multi-Fenestrated Septal Occluder – “Cribiform”

AGA Medical Corporation
Plymouth, MN
55442

Approval for an alternate source of routine bioburden and sterility testing, as well as changes to the bioburden testing protocol.

P000040/S028
7/9/13
Real-Time

Genesys HTA System

Boston Scientific Corporation
Marlborough, MA 01752

Approval for an energy directed welding process for the Genesys HTA filter assembly components.

P000040/S030
7/19/13
Real-Time

Genesys HTA System

Boston Scientific Corporation
Marlborough, MA 01752

Approval for a change to the gold thickness specification of the cassette contact pins from “flash gold” to ≥ 15 μ-inches and a modification to the shipper tray so that the contact pins do not contact its lid.

P010014/S044
7/30/13
Special

Oxford® Partial Knee System

Biomet Manufacturing Corporation
Warsaw, IN
46581

Approval for changes to the surgical technique manual.

P010015/S201
7/15/13
Real-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/S202
7/23/13
Real-Time

Attain, Consulta, InSync, Syncra Cardiac Resynchronization Therapy- Pacemaker (CRT-Ps)

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P010030/S042
7/22/13
180-Day

LifeVest Wearable Defibrillator

ZOLL LifeCor Corporation
Pittsburgh, PA
15238

Approval for software enhancements to the WCD 4000 LifeVest® Wearable Defibrillator and the subsequent display of that information on the secure LifeVest.

P010031/S376
7/15/13
Real-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/S377
7/23/13
Real-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 increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P010047/S025
7/15/13
180-Day

NeoMend ProGel Pleural Air Leak Sealant

NeoMend, Incorporated
Irvine, CA
92618

Approval for a change in the shipping temperature range to 1 °C to 30°C to allow for brief possible extremes in temperature during shipment. The Agency notes that the "Keep
Refrigerated" Label, C-00473, will to be affixed to the shipping container.

P010047/S026
7/25/13
180-Day

NeoMend ProGel Pleural Air Leak Sealant

NeoMend, Incorporated
Irvine, CA
92618

Approval for a change in the shipping temperature range to 1ºC to 30°C to allow
for brief possible extremes in temperature during shipment. The Agency notes that the "Keep
Refrigerated" Label, C-00473, will be affixed to the shipping container.

P010068/S032
7/22/13
135-Day

Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS Catheters

Biosense Webster, Inc.
Diamond Bar, CA 91765

Approval for the transfer of the Grinding Process from Irwindale, California manufacturing facility to Juarez, Mexico manufacturing facility.

P020024/S039
7/26/13
135-Day

AMPLATZER™ Duct Occluder

AGA Medical Corporation
Plymouth, MN
55442

Approval for an alternate source of routine bioburden and sterility testing, as well as changes to the bioburden testing protocol.

P020055/S008
7/25/13
Real-Time

PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems, Inc.
Tucson, AZ
85755

Approval for minor modifications to the design of the dispenser in
which the PMA reagents in the devices are stored and or used, including a change in the materials
the various dispenser parts are made from.

P030005/S099
7/25/13
Real-Time

Invive, Intua family 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 Application v1.09 and Ingenio Firmware version D_v1.02 with Patch v1.01 for the devices.

P030031/S050
7/22/13
135-Day

Celsius ThermoCool, Celsius RMT ThermoCool Catheters

Biosense Webster, Inc.
Diamond Bar, CA 91765

Approval for the transfer of the Grinding Process from Irwindale, California manufacturing facility to Juarez, Mexico manufacturing facility.

P030036/S058
7/23/13
Real-Time

SelectSecure Lead

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P040020/S045
7/23/13
180-Day

AcrySof ReSTOR Apodized Diffractive IOLs

Alcon Research, Ltd.
Fort Worth, TX 76134

Approval for a manufacturing site located at Alcon Research, Ltd., in Lesage, West Virginia.

P040036/S033
7/22/13
135-Day

NaviStar ThermoCool, Navistar RMT Thermocool, EZ Steer ThermoCool Catheters

Biosense Webster, Inc.
Diamond Bar, CA 91765

Approval for the transfer of the Grinding Process from Irwindale, California manufacturing facility to Juarez, Mexico manufacturing facility.

P040040/S023
7/26/13
135-Day

AMPLATZER™ Muscular VSD Occluder

AGA Medical Corporation
Plymouth, MN
55442

Approval for an alternate source of routine bioburden and sterility testing, as well as changes to the bioburden testing protocol.

P040044/S045
7/22/13
180-Day

Mynx Vascular Closure Device

AccessClosure, Inc.
Santa Clara, California
95054

Approval for a manufacturing site located in Santa Clara, California.

P050006/S035
7/17/13
Special

Gore Helex Septal Occluder

W.L. Gore & Associates
Flagstaff, AZ
86001

Approval to update the existing Gore Helex Septal Occluder Instructions for
Use.

P050023/S066
7/30/13
Real-Time

Lumax Family of ICD Devices and CRT-D Devices

Biotronik, Inc.
Lake Oswego, OR 97035

Approval for an alternate separator material used in the Litronik batteries for the devices.

P050023/S067
7/30/13
Real-Time

Ilesto 7 VR-T, Iforia 7 VR-T, Ilesto 5 VR-T, Iforia 5 VR-T, Lumax 700 VR-T, Lumax 600
VR-T, Lumax 740 VR-T, Lumax 640 VR-T, Ilesto 7 VR-T DX, Iforia 7 VR-T DX, Ilesto 5
VR-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 minor labeling modifications/
corrections, which
includes an update of the Indication for Use Statements (IFU) to include the market approved
devices with the same IFU, and other minor corrections to the labeling.

P060022/S016
7/1/13
Real-Time

Akreos AO60 Intraocular Lens (IOL)

Bausch & Lomb Incorporated
Aliso Viejo, CA 92656

Approval for a labeling change to include the addition of a new intraocular lens (IOL) inserter, INJ100, in the Directions for Use.

P060039/S047
7/23/13
Real-Time

Attain StarFix Lead

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P070008/S044
7/30/13
Real-Time

Entovis HF(-T), Evia HF(-T) Family of CRT-P Devices

Biotronik, Inc.
Lake Oswego, OR 97035

Approval for an alternate separator material used in the Litronik batteries for the devices.

P070026/S008
7/17/13
Real-Time

DePuy Ceramax Ceramic total Hip System

Depuy, Inc.
Warsaw, IN
46581

Approval for the addition of Summit Porocoat Stems as a compatible component to the existing 28mm ceramic head.

P070026/S014
7/2/13
180-Day

CERAMAX® Ceramic Total Hip System

Depuy, Inc.
Warsaw, IN
46581

Approval of the post-approval study protocol.

P080004/S011
7/10/13
180-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/S054
7/23/13
Real-Time

Attain Ability Lead

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P080011/S024
7/16/13
180-Day

CooperVision comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

CooperVision™, Incorporated
Pleasanton, CA 94588

Approval to add the new brand name Biofinity XR.

P080012/S016
7/2/13
Real-Time

Prometra Programmable Implantable Pump

Flowonix Medical, Incorporated
Mount Olive, NJ 07828

Approval for the addition of an alternate sub-tier supplier and material change for the molded silicone cannula strain relief and filter seal, which are both components of the implantable pump.

P080032/S012
7/3/13
180-Day

Alair Bronchial Thermoplasty System

Boston Scientific Corporation
Marlborough, MA 01752

Approval for 1) the manufacturing transfer of the Alair Catheter from the current facility in Sunnyvale, California, to the Boston Scientific facility in Cork, Ireland; and 2) the
qualification of Synergy Health Ireland Ltd, located in Tullamore, Ireland, as a sterilization site
for the Alair Catheter, and minor design changes to the Alair Catheter.

P090013/S098
7/15/13
Real-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/S099
7/23/13
Real-Time

CapSureFix MRI Lead, Revo MRI IPG

Medtronic, Inc.
Mounds View, MN 55112

Approval for an increase in the storage shelf life of the Tyvek lid component, which includes the adhesive coating, used in the Medtronic Cardiac Rhythm Disease Management products from 18 months to 48 months.

P090022/S017
7/25/13
Real-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 different delivery system, the device which holds the intraocular lens (IOL) in place within its saline filled vial.

P100010/S030
7/26/13
Real-Time

Arctic Front Cardiac CryoAblation Catheters, 
Arctic Front Advance Cardiac CryoAblation Catheters

Medtronic CryoCath LP
Marie Kirkland, Quebec, Canada
H9H 5H3

Approval for the removal of the outer leak detection wire and associated inductor.

P100022/S006
7/19/13
Special

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 improve clarity by providing recommendations for appropriate guidewire selection and additional instructions for when resistance is encountered during catheter use.

P100027/S007
7/22/13
Real-Time

INFORM HER2 Dual ISH DNA Probe

Ventana Medical Systems, Inc.
Tucson, AZ
85755

Approval for modifications in design to prevent waste system overflow or other leaks from causing shorting conditions with the BenchMark ULTRA’s internal circuits.

P100027/S009
7/25/13
Real-Time

INFORM HER2 Dual ISH DNA Probe

Ventana Medical Systems, Inc.
Tucson, AZ
85755

Approval for minor modifications to the design of the dispenser in
which the PMA reagents in the devices are stored and or used, including a change in the materials
the various dispenser parts are made from.

P100042/S001
7/15/13
180-Day

APTIMA® HPV Assay

Gen-Probe Incorporated
San Diego, CA
92121

Approval for the addition of the PANTHER System to the APTIMA® HPV Assay. The device, as modified, will be marketed under the trade name APTIMA® HPV Assay. The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35,
39, 45, 51, 52,56, 58, 59, 66, and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens collected in ThinPrep Pap Test vials containing PresesrvCyt Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the APTIMA HPV Assay. The assay is used with the TIGRIS DTS System or the PANTHER System.
The use of the test is indicated:
1) To screen women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy; and 2) In women 30 years and older, the APTIMA HPV Assay can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
*Broom-type device (e.g., Wallach Pipette) or endocervical brush/spatula.

P100044/S008
7/17/13
180-Day

Propel™ Mini Sinus Implant

Intersect ENT
Menlo Park, CA 94025

Revise the stability protocol to reflect the drug release acceptance criteria of ± 12% of the target value used for product release.

P100047/S022
7/3/13
Special

HeartWare Ventricular Assist System

HeartWare, Inc.
Miami Lakes, FL 33014

Approval for updates to the Instructions for Use and Patient Manual of the device to include warnings and information related to electrostatic discharge exposure and exchanging power sources.

P110010/S050
7/15/13
135-Day

PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail® and Over-The-Wire)

Boston Scientific Corporation
Maple Grove, MN 55311

Approval for an upgrade to an inspection system camera and software.

P110013/S017
7/2/13
180-Day

Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Medtronic Vascular
Santa Rosa, CA 95403

Approval for an updated Annual Stability protocol to bracket the additional 34 mm and 38 mm length stent sizes.

P110016/S003
7/30/13
180-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 passive sensor into the tip of the device for the purposes of aiding navigation 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 under the trade names Cool Path™ Duo Ablation Catheter, MediGuide Enabled™ and Safire™ Duo Ablation Catheter, MediGuide Enabled™ and are indicated for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of typical atrial flutter. The catheters are intended for use with a compatible external pump and the IBI-1500T9-CP RF Generator at a maximum of 50 watts. MediGuide Enabled™ Ablation Catheters are used with the MediGuide™ Technology to enable real-time tip positioning and navigation. The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy.

P110019/S043
7/15/13
Real-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 update the labeling for the Xience Xpedition, Xience Xpedition SV, and Xience Xpedition LL Everolimus Eluting Coronary Stent Rapid Exchange (RX) System to reflect a 24-month shelf life.

P110019/S045
7/26/13
180-Day

XIENCE PRIME Stent Systems

Abbott Vascular
Temecula, CA
92591

Approval of the post-approval study protocol.

P110021/S004
7/2/13
180-Day

Edwards SAPIENTM Transcatheter Heart Valve with RetroFlex 3 Delivery System Edwards SAPIENTM
Transcatheter Heart Valve with Ascendra Delivery System and accessories (RetroFlexTm Balloon Catheter, AscendraM Balloon Aortic Valvuloplasty Catheter,
Ascendram Introducer Sheath Set; and Crimper

Edwards Lifesciences, LLC
Irvine, CA
92614

Approval for design modifications to the Ascendra Balloon Catheter, Models
9100BCL23 (23mm) and 9100BCL26 (26mm), and the Ascendra Introducer Sheath Set, Model
91001S. The device, as modified, will be
marketed under the trade name Ascendra 3 Delivery System, Models 9120AS23 (23mm) and 9120AS26 (26mm) and Ascendra 3 Introducer Sheath Set, Model 9120IS (26F) and is indicated
for the transapical delivery of the Edwards SAPIEN Transcatheter Heart Valve (delivery system)
and for the introduction and removal of devices used with the Edwards SAPIEN Transcatheter
Heart Valve (introducer sheath set).

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS

N17600/S028
7/24/13

Avitene Microfibrillar Collagen Hemostat Product

Davol, Inc.
Warwick, RI
02886

Relocation of raw material processing equipment to a new building within the same raw material supplier address.

N970003/S153
7/3/13

Advantio, Ingenio, Vitalio, Formio family of Implantable Pulse Generators,
Application Software

Boston Scientific Corporation
St. Paul, MN
55112

Automation of a manual sieve process at a supplier and addition of a new requirement to source documentation for incoming acceptance.

P790007/S039
7/30/13

Hancock® Modified Orifice Valved Conduit

Medtronic, Inc.
Santa Ana, CA 92705

Newly constructed Controlled Environment Area (CEA) at the manufacturing facility in Santa Ana, CA.

P800002/S019
7/24/13

Avitene Microfibrillar Collagen Hemostat Product

Davol, Inc.
Warwick, RI
02886

Relocation of raw material processing equipment to a new building within the same raw material supplier address.

P810031/S049
7/30/13

Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, and Healon5  Products

Abbott Medical Optics, Inc.
Santa Ana, CA 92705

Alternate bulk package shipping configuration.

P830055/S135
7/17/13

LCS Total Knee System

DePuy Orthopaedics, Inc.
Warsaw, IN
46581

Changes to the inspection processes and inspection frequencies for the LCS Complete Poly Patella and LCS Complete Mobile Bearing Patella.

P830061/S096
7/3/13

CapSure Sense Bipolar Lead

Medtronic, Inc.
Mounds View, MN 55112

Additional sterilizer system at Medtronic’s Singapore Operations.

P840064/S054
7/24/13

VISCOAT and DUOVISC Ophthalmic Viscosurgical Devices

Alcon Laboratories, Inc.
Fort Worth, TX 76134

Reduction of the minimum aeration time for the blister packs.

P870056/S060
7/16/13

Carpentier-Edwards® Bioprosthetic Pulmonic Valved Conduit

Edwards Lifesciences, LLC
Irvine, CA
92614

Removal of a biological indicator requirement from the sterilization conventional release program to align with the latest version of the ISO 14160 (2011) for liquid chemical sterilization.

P870072/S056
7/16/13

Thoratec Ventricular Assist Device (VAD)

Thoratec Corporation
Pleasanton, CA 94588

Addition of a new Directional Flow Valve (DFV) Leak Tester.

P870078/S022
7/30/13

Hancock® Porcine Bioprosthesis

Medtronic, Inc.
Santa Ana, CA 92705

Newly constructed Controlled Environment Area (CEA) at the manufacturing facility in Santa Ana, California.

P900056/S124
7/10/13

Rotablator™ Rotational Atherectomy System

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the in-process straightness inspection criteria for the RotaWire
which is part of the Rotablator Rotational Atherectomy System.

P900060/S052
7/25/13

Carbomedics Prosthetic Heart Valve (CPHV™) device

Sorin Group USA, Inc.
Arvada, CO
80004

Addition of an alternate supplier for the Quality Control Inspection of Silicon
Content on the CPHV™ PyC components.

P930031/S045
7/9/13

WALLSTENT (TIPS) Endoprosthesis

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P930031/S046
7/18/13

WALLSTENT (TIPS) Endoprosthesis

Boston Scientific Corporation
Maple Grove, MN 55311

Additional vendor location to supply manufacturing aids and components used in the manufacturing process of the devices.

P930038/S071
7/1/13

Angio-Seal™ Vascular Closure Device

St. Jude Medical, Inc.
Plymouth, MN 55442

Elimination of the softwall controlled environment for the manufacturing of two device components.

P930039/S092
7/3/13

CapSureFix Novus Lead

Medtronic, Inc.
Mounds View, MN 55112

Additional sterilizer system at Medtronic’s Singapore Operations.

P940019/S039
7/9/13

WALLSTENT (Iliac) Endoprosthesis

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P950020/S063
7/9/13

Coronary Flextome Cutting Balloon

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P960040/S296
7/3/13

VENTAK AV and VENTAK PRIZM DRIVR, VITALITY, CONFIENT, and TELIGEN
Automatic Implantable Cardioverter Defibrillator Systems

Boston Scientific Corporation
St. Paul, MN
55112

Automation of a manual sieve process at a supplier and addition of a new requirement to source documentation for incoming acceptance.

P960040/S298
7/24/13

VENTAK AV and VENTAK PRIZM DRIVR, VITALITY, CONFIENT, and TELIGEN
Automatic Implantable Cardioverter Defibrillator Systems

Boston Scientific Corporation
St. Paul, MN
55112

BSC to manufacture the battery feedthru for the devices.

P960040/S299
7/24/13

VENTAK AV and VENTAK PRIZM DRIVR, VITALITY, CONFIENT, and TELIGEN
Automatic Implantable Cardioverter Defibrillator Systems

Boston Scientific Corporation
St. Paul, MN
55112

Boston Scientific Corporation to manufacture the battery halves case for the devices.

P960040/S300
7/30/13

VENTAK AV and VENTAK PRIZM DRIVR, VITALITY, CONFIENT, and TELIGEN
Automatic Implantable Cardioverter Defibrillator Systems

Boston Scientific Corporation
St. Paul, MN
55112

Change to the vacuum bake duration and number of optional re-bakes for an electrical component in the pulse generators for the devices.

P960040/S302
7/30/13

VENTAK AV and VENTAK PRIZM DRIVR, VITALITY, CONFIENT, and TELIGEN
Automatic Implantable Cardioverter Defibrillator Systems

Boston Scientific Corporation
St. Paul, MN
55112

Change in the supplier’s manufacturing process for the printed circuit
boards (PCBs) of the devices.

P970031/S043
7/30/13

Freestyle® Aortic Root Bioprosthesis

Medtronic, Inc.
Santa Ana, CA 92705

Newly constructed Controlled Environment Area (CEA) at the manufacturing facility in Santa Ana, CA.

P980006/S021
7/17/13

Bausch & Lomb PureVision (balafilcon A) Soft Contact Lens

Bausch and Lomb Incorporated
Rochester, NY 14609

Modification of the distillation process.

P980016/S422
7/3/13

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

Automation of the final packaging lines at the final device manufacturing
Facility at Medtronic in Puerto Rico.

P980016/S423
7/26/13

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

Update to the Next Generation Hybrid Tester to release 35.0.

P980016/S424
7/26/13

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

Change in the plating process manufacturing steps for the patient alert flex circuit assembly for the devices.

P980033/S034
7/9/13

WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P980033/S035
7/18/13

Wallstent Venous Endoprosthesis with Unistep Plus Delivery System

Boston Scientific Corporation
Maple Grove, MN 55311

Additional vendor location to supply manufacturing aids and components
used in the manufacturing process of the devices.

P980035/S332
7/3/13

Kappa 600, Kappa 650, Kappa 700, Kappa 800, Kappa 900, Adapta, Sensia, Relia,
Enpulse, Enrhythm, Advisa, Versa, Sigma IPG

Medtronic, Inc.
Mounds View, MN 55112

Additional sterilizer system at Medtronic’s Singapore Operations.

P980035/S333
7/3/13

Kappa 600, Kappa 650, Kappa 700, Kappa 800, Kappa 900, Adapta, Sensia, Relia,
Enpulse, Enrhythm, Advisa, Versa, Sigma IPG

Medtronic, Inc.
Mounds View, MN 55112

Automation of the final packaging lines at the final device manufacturing
Facility at  Medtronic in Puerto Rico.

P980035/S336
7/16/13

Kappa 600, Kappa 650, Kappa 700, Kappa 800, Kappa 900, Adapta, Sensia, Relia,
Enpulse, Enrhythm, Advisa, Versa, Sigma IPG

Medtronic, Inc.
Mounds View, MN 55112

Update to the final functional test application.

P980035/S337
7/30/13

Kappa 600, Kappa 650, Kappa 700, Kappa 800, Kappa 900, Adapta, Sensia, Relia,
Enpulse, Enrhythm, Advisa, Versa, Sigma IPG

Medtronic, Inc.
Mounds View, MN 55112

Addition of an automated wet saw cutting process.

P980043/S043
7/30/13

Hancock® II Bioprosthetic Heart Valve

Medtronic, Inc.
Santa Ana, CA 92705

Newly constructed Controlled Environment Area (CEA) at the manufacturing facility in Santa Ana, CA.

P980044/S015
7/12/13

SUPARTZ®

Seikagaku Corporation
Tokoyo, Japan
100-0005

Sharing of manufacturing equipment for use with an investigational product.

P980044/S016
7/25/13
SUPARTZ®Seikagaku Corporation
Tokoyo, Japan
100-0005
Use of newly constructed cleanroom doors and associated airlocks.

P990046/S033
7/26/13

Open Pivot Heart Valve

Medtronic, Inc.
Minneapolis, MN 55432

New piece of equipment intended to machine carbon orifice components.

P990064/S051
7/30/13

Mosaic® Porcine Bioprosthesis

Medtronic, Inc.
Santa Ana, CA 92705

Newly constructed Controlled Environment Area (CEA) at the manufacturing facility in Santa Ana, California.

P990074/S027
7/10/13

Natrelle Saline-Filled Breast Implants

Allergan
Goleta, CA
93117

Electronic Data Acquisition System (EDA) instead of via a chart recorder.

P000032/S041
7/15/13

Her Option Cryoablation Therapy System

Cooper Surgical Inc.
Trumbull, CT
06611

Addition of a new molding vendor for the Front Handle.

P010012/S331
7/3/13

CONTAK CD, EASYTRAK, LIVIAN, COGNIS, and ACUITY Spiral Automatic Implantable Cardiac Resynchronization Therapy Defibrillator Systems

Boston Scientific Corporation
St. Paul, MN
55112

Automation of a manual sieve process at a supplier and addition of a new requirement to source documentation for incoming acceptance.

P010012/S333
7/24/13

CONTAK CD, EASYTRAK, LIVIAN, COGNIS, and ACUITY Spiral Automatic Implantable Cardiac Resynchronization Therapy Defibrillator Systems

Boston Scientific Corporation
St. Paul, MN
55112

BSC to manufacture the battery feedthru for the devices.

P010012/S334
7/24/13

CONTAK CD, EASYTRAK, LIVIAN, COGNIS, and ACUITY Spiral Automatic Implantable Cardiac Resynchronization Therapy Defibrillator Systems

Boston Scientific Corporation
St. Paul, MN
55112

Boston Scientific Corporation to manufacture the battery halves case for the devices.

P010012/S335
7/30/13

CONTAK CD, EASYTRAK, LIVIAN, COGNIS, and ACUITY Spiral Automatic Implantable Cardiac Resynchronization Therapy Defibrillator Systems

Boston Scientific Corporation
St. Paul, MN
55112

Change to the vacuum bake duration and number of optional re-bakes for an electrical component in the pulse generators for the devices.

P010012/S337
7/30/13

CONTAK CD, EASYTRAK, LIVIAN, COGNIS, and ACUITY Spiral Automatic Implantable Cardiac Resynchronization Therapy Defibrillator Systems

Boston Scientific Corporation
St. Paul, MN
55112

Change in the supplier’s manufacturing process for the printed circuit boards (PCBs) of the devices.

P010013/S046
7/10/13

NovaSure Impedance Controlled Endometrial Ablation System

Hologic, Inc.
Marlborough, MA 01752

Manufacturing process change for one of the NovaSure Impedance Controlled Endometrial Ablation System components.

P010015/S206
7/16/13

Attain, Consulta, InSync, Syncra Cardiac Resynchronization Therapy- Pacemaker (CRT-Ps)

Medtronic, Inc.
Mounds View, MN 55112

Update to the final functional test application.

P010015/S207
7/30/13

Attain, Consulta, InSync, Syncra Cardiac Resynchronization Therapy- Pacemaker (CRT-Ps)

Medtronic, Inc.
Mounds View, MN 55112

Addition of an automated wet saw cutting process.

P010031/S383
7/3/13

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

Automation of the final packaging lines at the final device manufacturing Facility at Medtronic in Puerto Rico.

P010031/S384
7/26/13

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

Update to the Next Generation Hybrid Tester to release 35.0.

P010031/S385
7/26/13

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

Change in the plating process manufacturing steps for the patient alert flex circuit assembly for the devices.

P010032/S072
7/12/13

EonC 16-Channel Implantable Pulse Generator Neurostimulation System

St. Jude Medical
Plano, TX
75024

Automate the electrical processing for the printed circuit board of the EonC.

P020004/S083
7/11/13

Excluder AAA Endoprosthesis

W.L. Gore & Associates
Flagstaff, AZ
86001

Implementation of a new supplier of polytetrafluoroethylene (PTFE) tape using an alternate PTFE resin raw material.

P020004/S084
7/10/13

Excluder AAA Endoprosthesis

W.L. Gore & Associates
Flagstaff, AZ
86001

Implement the use of alternate polytetrafluoroethylene (PTFE) resin
raw material.

P020009/S108
7/9/13

Express2 Coronary Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P020056/S022
7/10/13

Natrelle Silicone-Filled Breast Implants

Allergan
Goleta, CA
93117

 Electronic Data Acquisition System (EDA) instead of via a chart recorder.

P030004/S007
7/19/13

Onyx Liquid Embolic System

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA
92618

Modifications to the router software.

P030005/S100
7/3/13

CONTAK RENEWAL TR and INVIVE CRT-P Systems

Boston Scientific Corporation
St. Paul, MN
55112

Automation of a manual sieve process at a supplier and addition of a new requirement to source documentation for incoming acceptance.

P030009/S065
7/26/13

Integrity Coronary Stent Systems

Medtronic Vascular
Santa Rosa, CA 95403

Modifications to the stent subassembly annealing process and upgrades to an
annealing oven.

P030017/S169
7/11/13

Precision Spectra Spinal Cord Stimulator System

Boston Scientific Corporation
Valencia, CA
91355

Update the test software for the Application Specific Integrated Circuit.

P030017/S170
7/12/13

Precision Spectra Spinal Cord Stimulator System

Boston Scientific Corporation
Valencia, CA
91355

Update the test software for the Electronic Assembly of the Implantable Pulse Generator.

P030017/S171
7/19/13

Precision and Precision Spectra Spinal Cord Stimulator Systems

Boston Scientific Corporation
Valencia, CA
91355

Expand the duration of the Lead reflow manufacturing step.

P030017/S172
7/30/13

Precision and Precision Spectra Spinal Cord Stimulator Systems

Boston Scientific Corporation
Valencia, CA
91355

Update the test equipment system for the charger.

P030017/S174
7/31/13

Precision and Precision Spectra Spinal Cord Stimulator Systems

Boston Scientific Corporation
Valencia, CA
91355

Update the test software for the Implantable Pulse Generator.

P040016/S114
7/9/13

VeriFLEX (Liberté) Coronary Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P040043/S054
7/11/13

TAG Thoracic Endoprosthesis

W.L. Gore & Associates
Flagstaff, AZ
86001

Implementation of a new supplier of polytetrafluoro-ethylene (PTFE) tape using an alternate PTFE resin raw material.

P040043/S055
7/10/13

TAG Thoracic Endoprosthesis

W.L. Gore & Associates
Flagstaff, AZ
86001

Implement the use of alternate polytetrafluoroethylene (PTFE) resin
raw material.

P040046/S004
7/10/13

Natrelle Highly Cohesive Silicone-Filled Breast Implants

Allergan
Goleta, CA
93117

 Electronic Data Acquisition System (EDA) instead of via a chart recorder.

P040047/S027
7/23/13

Coaptite Injectable Implant

Merz Aesthetics, Inc.
Franksville, WI 53126

Increase the manufacturing hold time for the gel.

P050006/S034
7/5/13

GORE® HELEX® Septal Occluder

W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001

Upgrade to the coating station timer and removal of a redundant quality
control test.

P050010/S012
7/10/12
Real-Time

ProDisc-LTM Total Disc Replacement

Synthes Spine, Inc.

West Chester, PA 19380

Approval of a protocol for extension of shelf-life for the polyethylene inlay component from three (3) years to five (5) years.

P050011/S004
7/2/13

ADEPT Adhesion Reduction Solution (4% Icodextrin)

Baxter Healthcare Corporation
Round Lake, IL 60073

Replace the current Peptidoglycan (PG) test method with a High Sensitivity PG (HS-PG) test method.

P050019/S015
7/9/13

Carotid WALLSTENT Monorail Endoprosthesis

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P050019/S016
7/18/13

Carotid WALLSTENT Monorail Endoprosthesis

Boston Scientific Corporation
Maple Grove, MN 55311

Additional vendor location to supply manufacturing aids and components
used in the manufacturing process of the devices.

P050037/S038
7/16/13

Radiesse Injectable Implant

Merz Aesthetics, Inc.
Franksville, WI 53126

Increased manufacturing hold time for the gel component of Radiesse.

P050051/S021
7/18/13

ARCHITECT AUSAB

Abbott Laboratories
Abbott Park, IL 60064

Addition of a quality control test for an incoming raw material.

P050052/S041
7/16/13

Radiesse Injectable Implant

Merz Aesthetics, Inc.
Franksville, WI 53126

Increased manufacturing hold time for the gel component of Radiesse.

P060006/S047
7/9/13

Express SD Renal Monorail Premounted Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P060007/S027
7/18/13

ARCHITECT HBsAg/HBsAg Confirmatory

Abbott Laboratories
Abbott Park, IL 60064

Addition of a quality control test for an incoming raw material.

P060008/S104
7/9/13

TAXUS Liberté Paclitaxel-Eluting Coronary Stent Systems

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P060018/S003
7/12/13

PRESTIGE® Cervical Disc

Medtronic Sofamor Danek USA, Inc.
Memphis, TN 38132

Change the sterilization testing procedure.

P060022/S017
7/10/13

Akreos Intraocular Lenses

Bausch & Lomb Incorporated
Aliso Viejo, CA 92656

Add an additional monomer supplier.

P060033/S077
7/10/13

Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems

Medtronic Vascular
Santa Rosa, CA 95403

Upgrade to the spray weigh automated system (SWAT III) and sprayer currently used on the Resolute Integrity and Endeavor Sprint devices.

P060033/S078
7/30/13

Endeavor Sprint Zotarolimus-Eluting Coronary Stent System

Medtronic Vascular
Santa Rosa, CA 95403

Software enhancements and updates to the Fourier Transform Near Infrared
(FT-NIR) system used for the incoming active pharmaceutical ingredient (API) identification testing.

P060033/S079
7/26/13

Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems

Medtronic Vascular
Santa Rosa, CA 95403

Modifications to the stent subassembly annealing process and upgrades to an
annealing oven.

P070014/S039
7/12/13

Bard® LifeStent® Vascular Stent System

Bard Peripheral Vascular, Inc. Tempe, AZ
85281

Acceptance for an alternate sub-supplier of tackifier resin to the approved supplier of sterile barrier pouches for the Bard® LifeStent® Vascular Stent Systems.

P080007/S017
7/2/13

Bard® E-LUMINEXX® Vascular Stent

C.R. Bard, Inc.
Tempe, AZ
85281

Add an alternate supplier for the catheter shaft in the delivery system.

P080011/S025
7/30/13

NeoMend ProGel Pleural Air Leak Sealant

CooperVision
Pleasanton, CA 94588

Relocation of Biofinity line #4 in the same production area and also a change in the molding machine platform.

P090003/S024
7/9/13

Express LD Iliac Premounted Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P090003/S025
7/18/13

Express LD Iliac Premounted Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Additional vendor location to supply manufacturing aids and components
used in the manufacturing process of the devices.

P090013/S103
7/3/13

CapSureFix MRI SureScan Lead

Medtronic, Inc.
Mounds View, MN 55112

Additional sterilizer system at Medtronic’s Singapore Operations.

P090013/S104
7/3/13

Revo MRI IPG

Medtronic, Inc.
Mounds View, MN 55112

Automation of the final packaging lines at the final device manufacturing
Facility at Medtronic in Puerto Rico.

P090013/S106
7/30/13

Revo MRI IPG

Medtronic, Inc.
Mounds View, MN 55112

Addition of an automated wet saw cutting process.

P090016/S007
7/16/13

Belotero Balance Dermal Filler

Merz Aesthetics, Inc.
Franksville, WI 53126

Change to the Protein content test method.

P090022/S018
7/3/13

Softec HD, Softec I, Softec HD PS and Softec HDO Intraocular Lenses

Lenstec, Inc.
Saint Petersburg, FL 33716

Inclusion of three additional steam sterilizer units.

P100022/S007
7/23/13

Zilver PTX Drug-Eluting Peripheral Stent

Cook, Inc.
Bloomington, IN 47402

Change in incoming acceptance activities and changes to the manufacturing
process and test method for the inner catheter.

P100023/S074
7/9/13

ION (Taxus Element) Coronary Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P100023/S075
7/28/13

ION™ (TAXUS® Element™) Paclitaxel-Eluting Coronary Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Modifications to reduce the inspection wait time for a molded manifold component.

P100041/S031
7/3/13

Edwards SAPIENS Transcatheter Heart Valve, and Accessories-
RetroFlex 3TM Delivery System,
RetroFlexTM Balloon Catheter,
EdwardsM Transfemoral Balloon Catheter, and
Crimper

Edwards Lifesciences LLC
Irvine, CA
92614

Three new fixtures used in the manufacturing process, removal of a deburr mandrel tool, and additional inspections associated with these changes.

P100041/S032
7/3/13

Edwards SAPIENS Transcatheter Heart Valve, and Accessories-
RetroFlex 3TM Delivery System,
RetroFlexTM Balloon Catheter,
EdwardsM Transfemoral Balloon Catheter, and
Crimper

Edwards Lifesciences LLC
Irvine, CA
92614

Implementation of a positioning fixture as an alternative manufacturing aid used while placing temporary stitches on tissue leaflets.

P100041/S033
7/11/13

Edwards SAPIENS Transcatheter Heart Valve, and Accessories-
RetroFlex 3TM Delivery System,
RetroFlexTM Balloon Catheter,
EdwardsM Transfemoral Balloon Catheter, and
Crimper

Edwards Lifesciences, LLC
Irvine, CA
92614

Modifications to the molds of some of the Crimper components.

P100041/S034
7/22/13

Edwards SAPIENS Transcatheter Heart Valve, and Accessories-
RetroFlex 3TM Delivery System,
RetroFlexTM Balloon Catheter,
EdwardsM Transfemoral Balloon Catheter, and
Crimper

Edwards Lifesciences LLC
Irvine, CA
92614

Replacing the mold used to form the soft tip component of the RetroFlex 3
delivery system.

P100047/S027
7/25/13

HeartWare Ventricular Assist System

HeartWare, Inc.
Miami Lakes, FL 33014

Change in the supplier of the patch used to cover the speaker on the device
Controller.

P110010/S055
7/9/13

PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P110010/S056
7/28/13

PROMUS Element™ Plus Everolimus-Eluting Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Modifications to reduce the inspection wait time for a molded manifold component.

P110011/S003
7/26/13

Assurant Cobalt Iliac Balloon-Expandable Stent System

Medtronic Vascular
Santa Rosa, CA 95403

Modifications to the stent subassembly annealing process and upgrades to an
annealing oven.

P110013/S014
7/10/13

Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems

Medtronic Vascular
Santa Rosa, CA 95403

Upgrade to the spray weigh automated system (SWAT III) and sprayer
currently used on the Resolute Integrity and Endeavor Sprint devices.

P110013/S018
7/30/13

Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Medtronic Vascular
Santa Rosa, CA 95403

Software enhancements and updates to the Fourier Transform Near Infrared
(FT-NIR) system used for the incoming active pharmaceutical ingredient (API) identification testing.

P110013/S019
7/26/13

Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems

Medtronic Vascular
Santa Rosa, CA 95403

Modifications to the stent subassembly annealing process and upgrades to an
annealing oven.

P110021/S017
7/3/13

Edwards SAPIENS Transcatheter Heart Valve, and Accessories-
RetroFlex 3TM Delivery System,
RetroFlexTM Balloon Catheter,
EdwardsM Transfemoral Balloon Catheter, and
Crimper

Edwards Lifesciences LLC
Irvine, CA
92614

Three new fixtures used in the manufacturing process, removal of a deburr mandrel tool, and additional inspections associated with these changes.

P110021/S018
7/3/13

Edwards SAPIENS Transcatheter Heart Valve, and Accessories-
RetroFlex 3TM Delivery System,
RetroFlexTM Balloon Catheter,
EdwardsM Transfemoral Balloon Catheter, and
Crimper

Edwards Lifesciences LLC
Irvine, CA
92614

Implementation of a positioning fixture as an alternative manufacturing aid used while placing temporary stitches on tissue leaflets.

P110021/S019
7/11/13

Edwards SAPIENS Transcatheter Heart Valve, and Accessories-
RetroFlex 3TM Delivery System,
RetroFlexTM Balloon Catheter,
EdwardsM Transfemoral Balloon Catheter, and
Crimper

Edwards Lifesciences, LLC
Irvine, CA
92614

Modifications to the molds of some of the Crimper components.

P110021/S020
7/22/13

Edwards SAPIENS Transcatheter Heart Valve, and Accessories-
RetroFlex 3TM Delivery System,
RetroFlexTM Balloon Catheter,
EdwardsM Transfemoral Balloon Catheter, and
Crimper

Edwards Lifesciences LLC
Irvine, CA
92614

Replacing the mold used to form the soft tip component of the RetroFlex 3
delivery system.

P110032/S005
7/18/13

Aorfix™ AAA Flexible Stent Graft System

Lombard Medical Technologies Inc.
Tempe, AZ
85284

Modified sterilization cycle.

P110035/S015
7/2/13

Epic Vascular Self-Expanding Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Upgraded equipment for one chamber of the sterilization facility.

P110035/S016
7/9/13

Epic Vascular Self-Expanding Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Change to the environmental monitoring data collection process.

P110035/S017
7/24/13

Epic™Vascular Self-Expanding Stent System

Boston Scientific Corporation
Maple Grove, MN 55311

Alternate ethylene oxide (EO) sterilization cycle for the Epic™ Vascular
Self-Expanding Stent System.

P110038/S002
7/10/13

Relay Thoracic Stent-Graft with Plus Delivery System

Bolton Medical, Inc.
Sunrise, FL
33325

Modification to increase the output capacity of a supplier’s component
processing.

P110042/S010
7/12/13

Subcutaneous Implantable Defibrillator (S-ICD®) System

Boston Scientific Corporation
St. Paul, Minnesota 55112

Use of manufacturing traceability and tracking system software.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 94

Summary of PMA Originals Under Review
Total Under Review: 60
Total Active: 28
Total On Hold: 32

Summary of PMA Supplements Under Review
Total Under Review: 566
Total Active: 394
Total On Hold: 172

Summary of All PMA Submissions Received
Originals: 2
Supplements: 72

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 94
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 108.8
FDA Time: 94.0 Day    MFR Time: 14.8 Days