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
PMA Original Approvals
None.
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE 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 APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE 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. |
