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PMA Final Decisions for April 2013

Wed, 06/26/2013 - 12:00am
U.S. Food & Drug Administration

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

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

None.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P830055/S133
4/12/13
Special
LCS® Total Knee System DePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Approval for an additional inspection step after the In Process Clean (IPC). The inspection will ensure that there will be no remaining polishing agents left on the Attune CR and Attune PS femoral components after the IPC step is performed. The Attune CR and Attune PS femoral components were previously approved as compatible components to the Class III rotating platform Attune tibial components.
P880086/231
4/23/13
135
 Identify, Verity, Victory, Zephyr, and Accent Family of Pacemakers St. Jude Medical
Sylmar, CA
91342
Approval for the use of a second source supplier for anchors used in your firm's ICD, CRT-D, Pacemaker, and CRT-P devices.
P890003/S259
4/3/13
180-Day
CareLink Home Monitor, CardioSight Reader, CareLink
Express Monitor and CareLink Network Device Data Management
Application
Medtronic, Inc.
Mounds View, MN
55112
Approval for the Evera Implantable Cardioverter Defibrillators.
P910001/S059
4/4/13
180-Day
Excimer Laser Coronary Atherectomy (ELCA) Catheter Spectranetics Corporation
Colorado Springs, CO
80921
Approval for a change to an adhesive primer used in the manufacture of the ELCA Eccentric (Ell) devices. Previously, you have used Loctite 793 which has been discontinued by the vendor.  The primer has been changed to Loctite 7701, a medical grade adhesive primer used for the same purpose.
P910023/S312
4/23/12
135-Day
Atlas/Atlas+, Atlas II/Atlas II+, Current, Current Accel, Current+, Epic/Epic II+, Fortify, Fortify Assura, and Ellipse Family of ICDs St. Jude Medical
Sylmar, CA
91342
Approval for the use of a second source supplier for anchors used in the firm's ICD, CRT-D, Pacemaker, and CRT-P devices.
P910077/S131
4/30/13
Real-Time
LATITUDE Patient Management System Boston Scientific Corporation
St. Paul, MN
55112
Approval for modifications to the Model 6430 AC Power Adapter.
P930038/S067
4/15/13
180-Day
Angio-Seal Vascular Closure Device St. Jude Medical
St. Paul, MN
55117
Approval for a manufacturing site located at St. Jude Medical, Inc., in Minnetonka, Minnesota.
P950005/S038
4/12/13
180-Day
Celsius, Celsius RMT, EZ Steer, EZ Steer DS Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a sterilization site located at  Sterigenics, s.a., in Verviers, Belgium.
P960043/S080
4/15/13
Panel-Track
Perclose® ProGlide™ Suture Mediated Closure System Abbott Vascular
Santa Clara, CA
95054
Approval for the Perclose® ProGlide™ Suture Mediated Closure System. This device is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5F to 21 F sheaths; for sheath sizes greater than 8F, at least two devices and the pre-close technique are required.
P970003/S157
4/3/13
Real-Time
PerenniaDURA Cyberonics Inc
Houston, Texas 77058
Approval for minor design and manufacturing changes to the PerenniaDURA Model 303 Lead.
P970021/S037
4/3/13
135-Day
GYNECARE THERMACHOICE III Uterine balloon Therapy System Ethicon, Inc.
Somerville, NJ
08876
Approval for a change in the resin supplier for the Thermachoice balloon.
P980016/S382
4/3/13
180-day
Evera XT DR , Evera XT DR, Evera S DR, Evera XT VR, Evera S VR, and Evera S VR Implantable Cardioverter Defibrillators and Application Software v1.0.1 Medtronic, Inc.
Mounds View, MN
55112
Approval for the Evera Implantable Cardioverter Defibrillators.
P980018/S017
4/18/13
180-Day
Herceptest™ Kit Dako Denmark A/S
Glostrup, Denmark
DK-2600
Approval for the DakoLink. v4.0 software for Herceptest™ Kit.
P980040/S039
4/15/13
Panel-Track
TECNIS® Toric 1-Piece Intraocular Lens (IOL Abbott Medical Optics Inc. (AMO)
Santa Ana, CA  92705
Approval of the TECNJS® Toric 1-Piece IOL, Models ZCT150, ZCT225, ZCT300 and ZCT400, and the TECNIS® Toric Calculator System. This device is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.
P990025/S032
4/12/13
180-Day
NaviStar, NaviStar RMT, EZ Steer Nav Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a sterilization site located at  Sterigenics, s.a., inVerviers, Belgium.
P990071/S018
4/12/13
180-Day
ThermoCool SF Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a sterilization site located at  Sterigenics, s.a., in Verviers, Belgium.
P000027/S017
4/10/13
135-Day
Elecsys® Free PSA CalSet Roche Diagnostics Corporation
Indianapolis, IN 46250
Approval for a transfer from packaging line 20 in Building 398, to packaging line 19 in Building 493 within the Mannheim, Germany site and to change the box and spacer element size, main and side label size, and label layout.
P010014/S042
4/25/13
Special
Oxford® Partial Knee System – Additional Inspection Criteria for the Oxford® Tibial Tray Biomet Manufacturing Corporation
Warsaw, IN
46581
Approval to amend the in-process inspection criteria used at the Warsaw, Indiana site, to include additional dimensional checks after the polishing step for the Oxford® Tibial Tray, to align with the Warsaw facility's standard practices.
P010030/S041
4/16/13
Real-Time
LifeVest Wearable Defibrillator ZOLL LifeCor Corporation
Pittsburgh, PA
15238
Approval for minor mechanical design modifications to improve the ruggedness of the LifeVest Model 4000 Battery Charger and a minor mechanical change to the Model 3000 Battery Pack.
P010032/S063
4/11/13
180-Day
EON™ Neurostimulation System, EON Mini™ Neurostimulation System and
EON C™ Neurostimulation System
St. Jude Medical, Inc.
Plano, TX
75024
Approval for replacing the current contraindication regarding use of the neurostimulator in patients with demand-type cardiac pacemakers with a warning statement that recommends interaction testing and avoiding unipolar programming of the neurostimulator.
P010047/S022
4/4/13
135-Day
ProGel Pleural Air Leak Sealant Neomend, Inc.
Irvine, CA
92618
Approval for change to a resin supplier.
P010068/S028
4/12/13
180-Day
Celsius DS, NaviStar DS, Navis
Star RMT DS, EZ Steer Nav DS Catheters
Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a sterilization site located at  Sterigenics, s.a., in Verviers, Belgium.
P020018/S049
4/24/13
Special
Zenith AAA Endovascular Graft Cook Incorporated
Bloomington, IN 47402
Approval for changes to the manufacturing and quality control procedures to provide additional inspection steps regarding the proximal barb alignment with the top cap side hole and barb soldering specification for the device.
P020050/S011
4/12/13
Real-Time
WaveNet™ Network System for use with the WaveLight® EX500 Excimer Laser
System and WaveLight® Analyzer II
Alcon Laboratories
Fort Worth, TX
76134
Approval to introduce the WaveNet™ Network system to facilitate data exchange between FDA approved/ cleared WaveLight® refractive/ therapeutic and diagnostic devices via a network server.
P030008/S010
4/12/13
Real-Time
WaveNet™ Network System for use with the WaveLight® EX500 Excimer Laser
System
Alcon Laboratories
Fort Worth, TX
76134
Approval to introduce the WaveNet™ Network system to facilitate data exchange between FDA approved/ cleared WaveLight® refractive/ therapeutic and diagnostic devices via a network server.
P030009/S063
4/12/13
Special
Integrity Coronary Stent System Medtronic Vascular
Santa Rosa, CA
95403
Approval for an update to the product labeling to add the acronym 'BMS' to the Integrity product and 'DES' to the Resolute Integrity product to the device's luer.
P030031/S042
4/12/13
180-Day
Celsius ThermoCool, Celsius RMT ThermoCool, NaviStar ThermoCool,
NaviStar RMT ThermoCool Catheters
Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a sterilization site located at  Sterigenics, s.a., in Verviers, Belgium.
P030035/S109
4/23/13
135-Day
Frontier, Frontier II, Anthem Family of CRT-Ps St. Jude Medical
Sylmar, CA
91342
Approval for the use of a second source supplier for anchors used in the firm's ICD, CRT-D, Pacemaker, and CRT-P devices.
P030053/S012
4/5/13
180-Day
MemoryGel Silicone Gel-filled Breast Implant Mentor Worldwide, LLC
Santa Barbara, CA
93111
Approval for the 6-year update patient and physician labeling for the MemoryGel™ Silicone Gel-filled Breast Implant.
P030054/S242
4/23/13
135-Day
Atlas+ HF/Atlas II HF, Atlas II+FH, Epic+, Epic HF, Epic II HF, Epic II+HF, Promote, Promote+, Promote RF, Promote Accel, Unify, Unify Quadra, and Quadra Assura Family of CRT-Ds St. Jude Medical
Sylmar, CA
91342
Approval for the use of a second source supplier for anchors used in your firm's ICD, CRT-D, Pacemaker, and CRT-P devices.
P040002/S039
4/16/13
180-Day
PowerLink System with IntuiTrak Delivery System Endologix, Inc.
Irvine, CA
92618
Approval for the addition of bilateral percutaneous access to the device labeling.
P040036/S031
4/12/13
180-Day
NaviStar ThermoCool, NaviStar RMT ThermoCool, EZ Steer ThermoCool,
EZ Steer ThermoCool Nav Catheters
Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a sterilization site located at  Sterigenics, s.a., in Verviers, Belgium.
P060025/S011
4/2/13
Special
3f® Aortic Bioprosthesis Medtronic, Inc.
Santa Ana, CA 92705
Approval for revisions to the labeling regarding the implantation technique for the bioprosthesis.
P070014/S036
4/12/13
180-Day
LifeStent Vascular Stent Systems Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for a sterilization site located at Sterigenics Belgium Petit Rechain, S.A., in Verviers, Belgium.
P070026/S004
4/2/13
Panel-Track
DePuy Ceramax Ceramic Total Hip System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for DePuy Ceramax Ceramic Total Hip System. This device is indicated for noncemented use in skeletally mature individuals undergoing primary total hip replacement surgery for rehabilitation of hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and post-traumatic arthritis.
P080007/S015
4/12/13
180-Day
E-Luminexx Vascular Stent Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for a sterilization site located at Sterigenics Belgium Petit Rechain, S.A., in Verviers, Belgium.
P080012/S011
4/9/13
Real-Time
Prometra Programmable Implantable Pump Flowonix Medical, Incorporated
Mount Olive, NJ 07828
Approval for additional printer driver for the Prometra Programmable Pump System Programmer Software.
P080012/S012
4/18/13
180-Day
Prometra Programmable Infusion Pump System Flowonix Medical, Inc.
Mount Olive, NJ 07828
Approval for a warehousing and distribution site located in Mansfield, Massachusetts.
P080014/S015
4/18/13
Real-Time
Cervista® HPV HR Assay Hologic, LP
Marlborough, MA
01752
Approval for a minor labeling change in the Cervista Operator's Manual.
P100012/S003
4/10/13
180-Day
PCM Cervical Disc NuVasive, Inc.
San Diego, CA 92121
Approval of the post-approval study protocol.
P100021/S021
4/16/13
180-Day
Endurant II AUI Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403
Approval for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System, a line extension to the current Endurant II Stent Graft System.  The device, as modified, will be marketed under the trade name Endurant II Stent Graft System. The Endurant II bifurcated stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.  The Endurant II Aorto-Uni-Iliac (AUI) Stent Graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II Stent Graft System is indicated for use in patients with the following characteristics: 1) Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories; 2) Proximal neck length of  ≥ 10mm; 3)Infrarenal neck angulation of  ≤ 60°; 4) Aortic neck diameters with a range of 19 to 32mm; 5) Distal fixation length(s) of ≥ 15 mm; 6) Iliac diameters with a range of 8 to 25mm; and 7) Morphology suitable for aneurysm repair.
P100024/S004
4/19/13
180-Day
HER2 CISH pharmDx™ Kit Dako Denmark A/S
Glostrup, Denmark
DK-2600
Approval for the DakoLink v4.0 software for HER2 CISH pharmDx™ kit.
P100034/S003
4/17/13
Real-Time
Novo-TTF-100A System Novocure, Ltd.
Portsmouth, NH
03801
Approval for software modification to add an alarm to the idle loop (the non-treatment loop) to indicate that the device is still powered on even when treatment is not active.
P100041/S024
4/18/13
Special
Edwards SAPIEN™ Transcatheter Heart Valve Crimper Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for implementation of more detailed Crimper manufacturing instructions and additional quality control steps to enhance the safety of the Crimper devices.
P100047/S010
4/23/13
135-Day
Heartware Left Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014
Approval for re-routing the Thermal Cut-Out wire and shortening the Thermal Cut-Out assembly length.
P110008/S001
4/23/13
180-Day
Coflex Interlaminar Stabilization Device Paradigm Spine, LLC.
New York, NY 10022
Approval of the post-approval study protocol.
P110013/S009
4/12/13
Special
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA
95403
Approval for an update to the product labeling to add the acronym 'BMS' to the Integrity product and 'DES' to the Resolute Integrity product to the device's luer.
P110016/S006
4/18/13
Real-Time
Therapy Cool Path Duo Bi-Directional Ablation Catheter Irvine Biomedical, Inc.
Irvine, CA
92614
Aproval for a modified catheter using a tip electrode with 12 irrigation holes from the currently approved Safire BLU Duo Bi-directional Ablation catheter with the shaft and handle of the currently approved Therapy Cool Path Bi-directional Ablation catheter. The device, as modified, will be marketed under the trade name Therapy Cool Path Duo Bi-directional catheter and is indicated for use with the compatible irrigation pump and 1500T9 CP Radiofrequency (RF) Generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of typical atrial flutter.
P110019/S041
4/25/13
180-Day
XIENCE Xpedition Stent System Abbott Vascular
Temecula, CA 92589
Approval for a sterilization site located at Abbott Nutrition Ireland, in Sligo, Ireland.
P110021/S010
4/18/13
Special
Edwards SAPIEN™ Transcatheter Heart Valve Crimper Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for implementation of more detailed Crimper manufacturing instructions and additional quality control steps to enhance the safety of the Crimper devices.
P110042/S007
4/30/13
Real-Time
Subcutaneous Implantable Defibrillator (S-ICD) System Cameron Health, Inc.
San Clemente, CA
92673
Approval for an alternate supplier of the Low Power Hybrid (LPH) assembly of the S-ICD® System, including new components for the LPH.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N12159/S031
4/23/13
Surgicel Family of Absorbable Hemostats Ethicon Incorporated
Somerville, NJ
08876
Introduction of new cutting equipment.
N18033/S072
4/29/13
VISTAKON (etafilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Change the quality control sampling plan for package integrity testing of VISTAKON Brand Contact Lenses.
P790007/S036
4/30/13
Hancock Modified Orifice Valved Conduit Medtronic Heart Valves
Santa Ana, CA 92705
Installation of a new compressed air system.
P810025/S033
4/24/13
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device Bausch & Lomb
Aliso Viejo, CA 92656
Add an alternate site for its working cell bank manufacturer, add an alternate vitamin supplier and change sourced chemicals to USP Grade.
P810031/S047
4/9/13
Sodium Hyaluronate Ophthalmic Viscoelastic Devices, Healon, Healon GV, and Healon5 Abbott Medical Optics Inc.
Santa Ana, CA 92705
Change to the in-process bioburden testing.
P830055/S131
4/10/13
LCS Total Knee System DePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Manufacturing change for femoral components.
P830061/S087
4/18/13
CapSure & Vitatron Lead Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P830061/S088
4/11/13
CapSure Lead, Vitatron Crystaline Lead, Vitatron Excellence PS+ Lead Medtronic CRDM
Mounds View, MN 55112
Automation of the destructive test analysis for monitored processes.
P840001/S237
4/17/13
RestorePrime® Neurostimulator, PrimeAdvanced® Neurostimulator, Itrel® 4 Programmable Neurostimulator for Spinal Cord
Stimulation, Restore® Neurostimulator,
RestoreUltra® Neurostimulator,
RestoreAdvanced® Neurostimulator,
RestoreSensor® Neurostimulator
Medtronic Neuromodulation
Minneapolis, MN
55432
Change in test sample size for certain connector components provided by the supplier.
P840064/S053
4/4/13
PROVISC,  VISCOAT, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Device Alcon Research Ltd.
Fort Worth, TX 76134
Use one generic “worst case” test biological indicator (BI) blister as an alternative to the product-specific BI blister for use during EtO sterilization.
P850089/S093
4/18/13
Capture Novus & Impulse Lead Medtronic, Inc.
Mounds View MN, 55112
Alternate suppliers for molded silicone components.
P850089/S094
4/11/13
CapSure SP Novus Lead, CapSure Z Novus Lead, Excellence SS+ Lead and Impulse II Lead Medtronic CRDM
Mounds View MN, 55112
Automation of the destructive test analysis for monitored processes.
P860004/S190
4/17/13
SynchroMed® II Infusion Pump Medtronic Neuromodulation
Minneapolis, MN
55432
Change in test sample size for certain connector components provided by the supplier.
P860057/S106
4/16/13
Carpentier-Edwards PERIMOUNT Pericardial Bioprostheses Edwards Lifesciences, LLC
Irvine, CA
92614
Addition of a terminal liquid sterilization oven.
P860057/S107
4/24/13
Carpentier-Edwards® PERIMOUNT® Pericardial Aortic Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Additional supplier for the packaging jars.
P870056/S058
4/24/13
Carpentier-Edwards® Porcine Aortic Bioprosthesis and Carpentier
-Edwards® Porcine Mitral Bioprosthesis
Edwards Lifesciences, LLC
Irvine, CA
92614
Additional supplier for the packaging jars.
P870072/052
4/1/13
Thoratec Ventricular Assist Device (VAD) System Thoratec Corporation 
Pleasanton, CA 94588
Addition of a new sterilization chamber.
P870077/S053
4/24/13
Carpentier-Edwards® Duraflex Low Pressure Porcine Mitral
Bioprosthesis and Carpentier-Edwards® Duraflex Low Pressure Mitral Bioprosthesis
with Extended Suture Ring
Edwards Lifesciences, LLC
Irvine, CA
92614
Additional supplier for the packaging jars.
P870078/S019
4/30/13
Hancock Low Porosity Valved Conduit Medtronic Heart Valves
Santa Ana, CA 92705
Installation of a new compressed air system.
P890003/S271
4/11/13
CapSure Lead, Service Kit-Pacemaker Repair Kit Medtronic CRDM
Mounds View, MN 55112
Automation of the destructive test analysis for monitored processes.
P890047/S040
4/4/13
PROVISC,  VISCOAT, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Device Alcon Research Ltd.
Fort Worth, TX 76134
Use one generic “worst case” test biological indicator (BI) blister as an alternative to the product-specific BI blister for use during EtO sterilization.
P900061/S119
4/11/13
End Cap, Sizing Sleeve, Upsizing Sleeve Medtronic CRDM
Mounds View, MN 55112
Automation of the destructive test analysis for monitored processes.
P920015/S105
4/18/13
Splitter/Adaptor Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P920015/S106
4/12/13
HV Splitter/Adaptor Medtronic, Inc.
Mounds View, MN 55112
Implementation of the manufacturing execution system version 7.9 at various internal
suppliers and final device manufacturing locations;
2) an additional supplier for extruded tubing;
transfer of incoming inspection location for various components;
3) modifications to a controlled environment; and
4)an alternate supplier of a silicone component.
P920015/S107
4/11/13
DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead and Transvene SVC Lead Medtronic CRDM
Mounds View, MN 55112
Automation of the destructive test analysis for monitored processes.
P920047/S056
4/1/13
Blazer Prime htd Boston Scientific Corporation
San Jose, CA
95134
Implementation of additional data storage in an electronic manufacturing traceability system, increase in in-process inspection frequency, and elimination of an inspection step at batch setup.
P920047/S057
4/18/13
EPT-1000 Cardiac Ablation System Boston Scientific Corporation
San Jose, CA
95134
Introduce and allow the use of a new test fixture for the Out-of-Plane inspection.
P930014/S067
4/17/13
AcrySof Intraocular Lenses Alcon Laboratories, Inc.
Fort Worth, TX 76134
An alternate EO sterilization vendor.
P930029/S039
4/11/13
RF Conductr 5 mm, RF Conductr 4 mm, RF Contactr 5 mm, RF Enhancer II
4 mm, RF Marinr
4 mm, RF Marinr
4 mm and RF Marinr Unipolar
4 mm
Medtronic CRDM
Mounds View, MN 55112
Automation of the destructive test analysis for monitored processes.
P930031/S042
4/18/13
WALLSTENT® (TIPS) Endoprosthesis Boston Scientific Corporation
Maple Grove, MN 55311
Eliminate an in-process verification activity.
P930039/S083
4/18/13
CapSureFix and Vitatron Lead Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P930039/S084
4/11/13
CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead and Vitatron Crystalline Lead Medtronic CRDM
Mounds View, MN 55112
Automation of the destructive test analysis for monitored processes.
P940019/S036
4/18/13
WALLSTENT® (Iliac) Endoprosthesis Boston Scientific Corporation
Maple Grove, MN 55311
Eliminate an in-process verification activity.
P940035/S009
4/2/13
NMP22 BladderChek Test Alere Scarborough, Inc.
Scarborough, ME 04074
Increase the manufacturing efficiency of the assembled cassette by modifying the assembly method used in the manufacture of NMP22 BladderChek from
assembled and pouched manually by hand by operators, to be assembled by validated automated
equipment.
P950005/S043
4/25/13
Celsius, Celsius RMT, EZ Steer Non-Temp sensing Ablation Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Change in the sterilization release method and to establish minimum
specifications for chamber parameters for two of the chambers used.
P950024/S047
4/11/13
Capsure Epicardial Pacing Lead Medtronic CRDM
Mounds View, MN 55112
Automation of the destructive test analysis for monitored processes.
P960009/S168
4/17/13
Activa® PC Neurostimulator and
Activa® SC Neurostimulator
Medtronic Neuromodulation
Minneapolis, MN
55432
Change in test sample size for certain connector components provided by the supplier.
P960040/S289
4/19/13
Incepta, Energen, Punctua ICD’s Boston Scientific Corporation
St. Paul, MN
55112
Alternate suppliers for MOSFET and MOSIGT transistors.
P960040/S290
4/26/13
Punctua, Cognis, Energen, and Incepta Implantable Cardioverter
Defibrillators
Boston Scientific Corporation
St. Paul, MN
55112
Changes to the battery manufacturing process monitoring.
P960040/S291
4/12/13
PUNCTA, TELIGEN, ENERGEN, and INCEPTA ICDs Boston Scientific Corporation
Saint Paul, MN
55112
New software routine for the High Voltage Capacitor manufacturing process.
P960040/S292
4/26/13
INCEPTA, ENERGEN,  PUNCTUA,  TELIGEN Boston Scientific Corporation
Saint Paul, MN
55112
Optimization of weld process parameters and removal of a weld inspection
criterion for the  devices.
P960040/S293
4/30/13
Punctua, Teligen, Energen and Incepta Families of Implantable
Cardioverter Defibrillators
Boston Scientific Corporation
St. Paul, MN
55112
Automation of the existing process for the feedthru weld leak test.
D970003/S150
4/25/13
INGENIO and ADVANTIO Pacemakers Boston Scientific Corporation
St. Paul, MN
55112
Add an additional laser weld system to the manufacturing process.
P970003/S159
4/3/13
Pulse® and Pulse Duo® Generators, Demipulse® and Demipulse Duo® Generators,
AspireHC® Generator
Cyberonics, Inc.
Houston, TX
77058
Addition of storage/processing requirements for certain components.
P970003/S160
4/12/13
VNS Therapy System Cyberonics Inc
Houston, TX
77058
The addition of a quality inspection step for power adapter cables.
P970004/S154
4/17/13
InterStim® II Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Change in test sample size for certain connector components provided by the supplier.
P970031/S040
4/30/13
Freestyle Aortic Root Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Installation of a new compressed air system.
P980016/S403
4/4/13
Maximo, Protecta, Secura, and Virtuoso ICDs Medtronic, Inc.
Mounds View, MN 55112
Addition of an additional assembly line work cell.
P980016/S404
4/4/13
Intrinsic, Marquis, Maximo, Protecta, Secura, Virtuoso ICD Medtronic, Inc.
Mounds View, MN 55112
Changes to lot release testing and acceptance of device components.
P980016/S405
4/18/13
Maximo, Protecta & Secura ICD Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P980016/S406
4/30/13
Maximo II ICD, Protect ICD, Protecta XT ICD, Secura ICD and Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN 55112
Additional inspection activity during the manufacturing of batteries.
P980016/S411
4/26/13
Evera S DR, Evera S VR, Evera XT DR ICD Families Medtronic, Inc.
Mounds View, MN 55112
Additional assembly line wire bond work cell, and changes to lot release testing and acceptance of gold plated device components.
P980033/S031
4/18/13
WALLSTENT® (Venous) Endoprosthesis Boston Scientific Corporation
Maple Grove, MN 55311
Eliminate an in-process verification activity.
P980035/S314
4/4/13
Adapta, Versa, Sensia, Advisa, Relia Pacemaker Medtronic, Inc.
Mounds View, MN 55112
Changes to lot release testing and acceptance of device components.
P980035/S316
4/11/13
Advisa DR, Advisa DR MRI IPGs Medtronic CRDM
Mounds View, MN 55112
Reduction of the hybrid burn-in time for the Advisa DR and Advisa DR MRI IPGs.
P980043/S040
4/30/13
Hancock® II Porcine Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Installation of a new compressed air system.
P980050/S080
4/11/13
Transvene Lead Medtronic CRDM
Mounds View, MN 55112
Automation of the destructive test analysis for monitored processes.
P990001/S110
4/4/13
Vitatron Pacemaker Medtronic, Inc.
Mounds View, MN 55112
Changes to lot release testing and acceptance of device components.
P990025/S036
4/25/13
NaviStar, NaviStar RMT, EZ Steer Nay Catheters and BWI Cables Biosense Webster, Inc.
Diamond Bar, CA 91765
Change in the sterilization release method and to establish minimum
specifications for chamber parameters for two of the chambers used.
P990064/S048
4/30/13
Mosaic® Porcine Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Installation of a new compressed air system.
P990071/S022
4/25/13
RF Generator and Accessories/Accessory Cables Biosense Webster, Inc.
Diamond Bar, CA 91765
Change in the sterilization release method and to establish minimum
specifications for chamber parameters for two of the chambers used.
P990081/S016
4/2/13
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Add an alternate qualified supplier for subassemblies used in the
production of the BenchMark ULTRA and BenchMark XT instruments, critical components
used in the manufacture of the subject reagents.
P000007/S040
4/24/12
Edwards Prima Plus Stentless Porcine Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Additional supplier for the packaging jars.
P000053/S048
4/30/13
AMS 800 Artificial Urinary Sphincter American Medical Systems, Inc.
Minnetonka, MN 55343
Replacement of a manual Pressure Testing Unit with a semi-automated Pressure Tester Unit.
P010012/S324
4/19/13
Incepta, Energen, Punctua CRT-D’s Boston Scientific Corporation
St. Paul, MN
55112
Alternate suppliers for MOSFET and MOSIGT transistors.
P010012/S325
4/26/13
Punctua, Cognis, Energen, and Incepta Cardiac Resynchronization
Therapy Defibrillators
Boston Scientific Corporation
St. Paul, MN
55112
Changes to the battery manufacturing process monitoring.
P010012/S326
4/12/13
PUNCTUA, COGNIS, ENERGEN, and INCEPTA CRT-Ds Boston Scientific Corporation
Saint Paul, MN
55112
New software routine for the High Voltage Capacitor manufacturing process.
P010012/S327
4/26/13
Incepta, Energen, Punctua, Cognis Boston Scientific Corporation
Saint Paul, MN
55112
Optimization of weld process parameters and removal of a weld inspection
criterion for the  devices.
P010012/S328
4/30/13
Punctua, Cognis, Energen and Incepta Families of Cardiac
Resynchronization Therapy Defibrillators
Boston Scientific Corporation
St. Paul, MN
55112
Automation of the existing process for the feedthru weld leak test.
P010015/S194
4/4/13
Consulta, Syncra CRT-P Medtronic, Inc.
Mounds View, MN 55112
Changes to lot release testing and acceptance of device components.
P010015/S195
4/11/13
Attain Bipolar OTW Lead, LV pacing Lead Medtronic CRDM
Mounds View, MN 55112
Automation of the destructive test analysis for monitored processes.
P010015/S196
4/11/13
Consulta and Syncra CRT-Ps Medtronic CRDM
Mounds View, MN 55112
Reduction of the hybrid burn-in time for the Consulta and Syncra CRT-Ps .
P010031/S366
4/4/13
Brava, Concerto, Consulta, Maximo, Protecta, and Viva CRT-Ds Medtronic, Inc.
Mounds View, MN 55112
Addition of an additional assembly line work cell.
P010031/S367
4/4/13
Brava, Viva, Concerto, Consulta, InSync, Maximo, Protecta CRT-D Medtronic, Inc.
Mounds View, MN 55112
Changes to lot release testing and acceptance of device components.
P010031/S368
4/18/13
Consulta ICD, Maximo & Protecta CRT-D Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P010031/S369
4/30/13
Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD, Maximo II CRT-D, Protecta CRT-D and Protecta XT CRT-D Medtronic, Inc.
Mounds View MN, 55112
Additional inspection activity during the manufacturing of batteries.
P010032/S070
4/10/13
Genesis Neurostimulation Systems St. Jude Medical, Inc.
Plano, TX
75024
Manufacturing change for percutaneous leads and terminal end leads.
P010041/S042
4/24/13
Carpentier-Edwards® S.A.V. Aortic Porcine Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Additional supplier for the packaging jars.
P010047/S029
4/24/13
Progel Pleural Air Leak Sealant Neomend, Inc.
Irvine, CA
92618
Changes in the sterilization procedures for the Extended Tips and Spare Tips provided with the Progel Pleural Air Leak Sealant kit.
P010068/S033
4/25/13
Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Change in the sterilization release method and to establish minimum
specifications for chamber parameters for two of the chambers used.
P020011/S007
4/8/13
VERSANT® HCV RNA Qualitative Assay/ APTIMA® HCV RNA Qualitative Assay Gene-Probe Incorporated
San Diego, CA 92121
Change for modification of a Quality Control (QC) panel member which will be used in release testing of the final approved device.
P020025/S039
4/1/13
Blazer Prime XP Cardiac Ablation Catheters Boston Scientific Corporation
San Jose, CA
95134
Implementation of additional data storage in an electronic manufacturing traceability system, increase in in-process inspection frequency, and elimination of an inspection step at batch setup.
P020025/S040
4/18/13
EPT-1000XP Cardiac Ablation System Boston Scientific Corporation
San Jose, CA
95134
Introduce and allow the use of a new test fixture for the Out-of-Plane inspection.
P020055/S006
4/2/13
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Add an alternate qualified supplier for subassemblies used in the
production of the BenchMark ULTRA and BenchMark XT instruments, critical components
used in the manufacture of the subject reagents.
P030005/S097
4/25/13
INVIVE CRT-P Boston Scientific Corporation
St. Paul, MN
55112
Add an additional laser weld system to the manufacturing process.
P030017/S158
4/16/13
Precision and Precision Spectra Spinal Cord Stimulator Systems Boston Scientific Corporation
Valencia, CA
91355
Change the stylet handle.
P030017/S159
4/17/13
Precision and Precision Spectra Spinal Cord Stimulator Systems Boston Scientific Corporation
Valencia, CA
91355
Allow modifications to the sterilization equipment and associated sterilization cycle for the devices.
P030017/S160
4/12/13
Precision and Precision Spectra Spinal Cord Stimulator (SCS) System Boston Scientific Neuromodulation
Valencia, CA
91355
Alternate welder for a manufacturing process.
P030017/S162
4/30/13
Precision Spectra Spinal Cord Stimulator System Boston Scientific Neuromodulation
Valencia, CA
91355
Add an alternate sub-supplier for the feedthrough flange and to add an alternate vacuum bake oven for the feedthrough.
P030031/S051
4/25/13
Celsius ThermoCool, Celsius RMT ThermoCool Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Change in the sterilization release method and to establish minimum
specifications for chamber parameters for two of the chambers used.
P030036/S054
4/18/13
Anchor Sleeve Kit Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P030036/S055
4/11/13
Anchoring Sleeve Kit, SelectSecure Lead Medtronic CRDM
Mounds View MN, 55112
Automation of the destructive test analysis for monitored processes.
P030054/S244
4/11/13
Promote, Promote+. Promote RF, Promote Accel, Unify, Quicksite, QuickFlex,
QuickFlex XL, QuickFlex t, Quicksite,
Quicksite XL,
Atlas+ HF,
Atlas II HF,
Atlas II+ HF,
Epic HF, Epic II HF, Epic+ HF,
Epic II+ HF, Housecall CRT-D Devices
St. Jude Medical
Sunnyvale, CA 94085
An alternate supplier for Merlin PCS accessories.
P040020/S046
4/17/13
ReSTOR Intraocular Lenses Alcon Laboratories, Inc.
Fort Worth, TX 76134
An alternate EO sterilization vendor.
P040027/S030
4/29/13
GORE® VIATORR® TIPS Endoprosthesis W.L. Gore and Associates, Inc.
Flagstaff, AZ
86004
Change from a heat stamping to a laser marking method.
P040036/S035
4/25/13
NaviStar-, Navistar RMT-, EZ Steer- ThermoCool Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Change in the sterilization release method and to establish minimum
specifications for chamber parameters for two of the chambers used.
P040037/S046
4/18/13
GORE VIABAHN Endoprosthesis and
GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
W.L. Gore and Associates
Flagstaff, AZ
86001
Add an alternate supplier for the transition component of the “V3.18” catheter
delivery system.
P040045/S039
4/29/13
VISTAKON (senofilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Change the quality control sampling plan for package integrity testing of VISTAKON Brand Contact Lenses.
P050037/S036
4/23/13
Radiesse® Dermal Filler Merz Aesthetics, Inc.
Franksville, WI
53126
Elimination of BI sterility monitoring for the 3.0 cc Radiesse Injectable Implant.
P050038/S016
4/5/13
ARISTA AH Absorbable Hemostat ARISTA AH Absorbable Hemostat MEDAFOR, Inc.
Minneapolis MN 55430
Removal of the shrink wrap from the outer shelf box cartons.
P050052/039
4/23/13
Radiesse® Dermal Filler Merz Aesthetics, Inc.
Franksville, WI
53126
Elimination of BI sterility monitoring for the 3.0 cc Radiesse Injectable Implant.
P060002/S030
4/22/13
FLAIR® Endovascular Stent Graft Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
Implement a new system for printing product labels for the device.
P060002/S031
4/29/13
FLAIR® Endovascular Stent Graft Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
Change to parametric release of ethylene oxide sterilized product.
P060039/S042
4/18/13
Attain StarFix Lead Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P060039/S043
4/11/13
Attain StarFix Lead Medtronic CRDM
Mounds View, MN 55112
Automation of the destructive test analysis for monitored processes.
P060040/S025
4/1/13
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation 
Pleasanton, CA 94588
Addition of a new sterilization chamber.
P070014/S038
4/22/13
LIFESTENT® Vascular Stent Systems Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
Implement a new system for printing product labels for the device.
P080006/S050
4/18/13
Ability lead Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P080006/S051
4/11/13
Attain Ability Lead Medtronic CRDM
Mounds View, MN 55112
Automation of the destructive test analysis for monitored processes.
P080007/S016
4/22/13
E-LUMINEXX® Vascular Stent Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
Implement a new system for printing product labels for the device.
P080012/S014
4/9/13
Prometra Programmable Infusion Pump System Flowonix Medical,Inc.
500 International Drive, Suite 200
Mount Olive, New Jersey, 07828
Addition of an alternate sub-tier supplier for a component of the Prometra Programmable Infusion Pump System.
P080025/S050
4/17/13
InterStim® II Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Change in test sample size for certain connector components provided by the supplier.
P090013/S088
4/4/13
Revo Pacemaker Medtronic, Inc.
Mounds View, MN 55112
Changes to lot release testing and acceptance of device components.
P090013/S089
4/11/13
CapSureFix MRI Lead Medtronic CDRM
Mounds View, MN
55112
Automation of the destructive test analysis for monitored processes.
P090013/S090
4/11/13
Revo MRI IPG Medtronic CRDM
Mounds View, MN 55112
Reduction of the hybrid burn-in time for the Revo MRI IPG.
P090022/S016
4/5/13
Softec HD, Softec I, Softec HD PS and Softec HDO Intraocular Lenses Lenstec, Inc.
Saint Petersburg, FL 33716
Requested the use of a different endotoxin test method.
P100018/S006
4/2/13
Pipeline Embolization Device (PED) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, California 92618
Change the software used to generate printed work orders.
P100027/S006
4/2/13
INFORM HER2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc.
Tucson, AZ
85755
Add an alternate qualified supplier for subassemblies used in the
production of the BenchMark ULTRA and BenchMark XT instruments, critical components
used in the manufacture of the subject reagents.
P100041/S023
4/24/13
Edwards SAPIEN® Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Additional supplier for the packaging jars.
P100047/S018
4/2/13
HeartWare Left Ventricular Assist Device System Heartware, Inc.
Miami Lakes, FL
33014
Conduct LAL pyrogen testing on components of the Left Ventricular Assist Device obtained from pre-sterile assembly lots.
P100049/S005
4/17/13
LINX Reflux Management System Torax Medical Inc.
Shoreview, MN 55126
Update in manufacturing process.
P110007/S002
4/9/13
Healon EndoCoat Ophthalmic Viscosurgical Device (3% Sodium Hyaluronate) Abbott Medical Optics Inc.
Santa Ana, CA 92705
Change to the in-process bioburden testing.
P110012/S003
4/17/13
Vysis ALK Break Apart FISH Probe Kit and ProbeChek ALK Negative Control Slides Abbott Molecular, Inc.
Des Plaines, IL 60018
Three manufacturing changes, including the addition of a Working Cell Bank, implementation of a pre-fermentation optical density reading, and modification to propagating the cell line used to make Negative Control Slides.
P110021/S009
4/24/13
Edwards SAPIEN® Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Additional supplier for the packaging jars.
P110035/S010
4/10/13
Epic™ Vascular Self-Expanding Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Implement the use of a fixture in the manufacturing process to set the stent material properties and align the stent struts prior to inspection.
P110035/S011
4/18/13
Epic™ Vascular Self-Expanding Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Eliminate an in-process verification activity.
P110042/S006
4/11/13
SQ-RX Pulse Generator (PG) Cameron Health, Inc
San Clemente, CA
92673
Use ambient conditions for all curing steps in PG manufacturing.
P120005/S004
4/11/13
Dexcom G4 PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Manufacturing process change to the automated fluidics dipper sensor for the resistance membrane layer of the G4 PLATINUM sensor.

Total Under Review: 50
Total Active:15
Total On Hold: 35   

Summary of PMA Supplements Under Review
Total Under Review: 613   
Total Active: 437  
Total On Hold: 176         

Summary of All PMA Submissions Received
Originals: 2        
Supplements: 127      

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 51        
Number of Denials: 0   
Average Days Fr Receipt to Decision (Total Time): 179         
FDA Time: 161.5 Days      MFR Time: 17.5 Days

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