The Food & Drug Administration released a list of pre-market approvals granted in November 2011:
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P080018 11/3/10 |
Kodak DirectView CR Mammography System | Carestream Health, Inc. Rochester, NY 14608 |
Approval for the Kodak DirectView CR Mammography System. This device is indicated for The KODAK DirectView CR Mammography Feature together with KODAK DirectView CR Mammography Cassette comprise a device which, when used in conjunction with a KODAK DirectView CR System and a mammographic x-ray machine, generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P810031/S038 11/22/10 180-Day |
Sodium Hyaluronate Opthalmic Viscoelastic Devices (OVD), Healon®, Healon GV®, Healon 5® Products | Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Approval for a labeling change to update the labeling that was approved under PMA supplement P810031/S017 to reflect the Abbott branding guidelines. |
| P820003/S095 11/10/10 135-Day |
Disposable Cover | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P830060/S062 11/10/10 180-Day |
Lead Tunneler | Boston Scientific CRV St. Paul, MN 55112 |
Approval for Endotak Reliance 4-Site Leads and Accessories. |
| P830061/S052 11/10/10 135-Day |
CapSure, CapSure Sense, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence PS+, and Vitatron Excellence+ Families of Leads | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P840001/S158 11/1/10 135-Day |
Spinal Cord Stimulation | Medtronic, Inc. Minneapolis, MN 55432 | Approval for changes to electrical test software. |
| P850089/S066 11/10/10 135-Day |
CapSure, CapSure Z Novus, Capsure SP Novus, Capsure Fix, STERx Tip Pacing Lead (ventricular), Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse, and Vitatron Impulse II Families of Leads | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P870072/S045 11/5/10 Real-Time |
TLC-II PLUS Portable VAD Driver | Thoratec Corporation Pleasanton, CA 94588 | Approval for increasing the service interval for the TLC-II PLUS Portable VAD Driver from 4500 hours to 8000 hours. |
| P890003/S194 11/10/10 135-Day |
CapSure Family of Leads, Brilliant S+ VDD Family of Leads, Service Kit-Pacemaker Repair Kit, ECG Cable, Prodigy, Thera-I, Vitatron Legacy, Vitatron Legacy II, and Vitatron Visa Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P900061/S091 11/10/10 135-Day |
Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, Transvene Defibrillation Lead, Epicardial patch lead, and ACE header, Lead end pin cap, Gem, PCD Tachy Control System, Jewel, Micro Jewel, and Micro Jewel II Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P910073/S077 11/10/10 180-Day |
Endotak Reliance 4-Site Lead; 4-Site Terminal Tool; Lead Cap Kit; and 4-Site Lead Pulling Tip | Boston Scientific CRV St. Paul, MN 55112 |
Approval for Endotak Reliance 4-Site Leads and Accessories. |
| P910077/S109 11/19/10 Real-Time |
Latitude Inductive Communicator | Boston Scientific CRM St. Paul, MN 55112 |
Approval for modifications to the software for the Latitude Inductive Communicator (Model 6481). |
| P920015/S061 11/10/10 135-Day |
IS-1 Connector Port Pin plug kit, “Y” adaptor/extender kit, Lead adaptor, Sub-Q Tunneling Tool, Sprint, Sprint Quattro, SUBUTANEOUS, Transvene CS/SVC, Transvene DFI, Transvene RV, Transvene SubQ, and Transvene SVC Families of Leads | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P920015/S069 11/10/10 Special |
Spring Quattro | Medtronic, Inc. Mounds View, MN 55112 |
Approval for labeling changes warning physicians about over-retraction of the helix in the subject leads. |
| P930029/S023 11/10/10 135-Day |
RF Marinr, RF Mainr NTC, 5F RF Marinr, RF Conductr, RF Enhancr II, RF Contactr Families of Ablation Catheters | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P930039/S039 11/10/10 135-Day |
CapSure, CapsureFix Novus, CapsureFix, SureFix, Vitatron Crystalline ActFix, and Vitatron Pirouet S+ Families of Leads | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P940015/S018 11/24/10 135-Day |
Synvisc (Hylan G-F 20) and Synvisc-One (Hylan G-F 20) | Genzyme Corporation Cambridge, MA 02142 | Approval for the introduction of Fedegari autoclave as an additional autoclave in the manufacturing process. |
| P950024/S021 11/10/10 135-Day |
Capsure Epicardial Pacing Family of Leads | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P950037/S083 11/26/10 180-Day |
Evia/Entovis Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Atrial Capture Control and Ventricular Pacing Suppression features included in version 1002.U/1 programmer software for the Evia/Entovis pulse generators. |
| P960009/S089 11/1/10 135-Day |
Activa® Deep Brain Stimulation Therapy | Medtronic, Inc. Minneapolis, MN 55432 | Approval for changes to electrical test software. |
| P960013/S057 11/26/10 180-Day |
OptiSense Model 1999 Right Atrial Lead | St. Jude Medical Sylmar, CA 91342 |
Approval for a design change to the header coupling (from a machined component to a molded component) of the OptiSense Model 1999 pacing and sensing lead. |
| P960016/S034 11/18/10 Real-Time |
Safire™ Cardiac Ablation System | St. Jude Medical Minnetonka, MN 55345 | Approval for a minor design change to widen the minimum angular specification of the pierced hole on the Safire™ shaft. |
| P960040/S198 11/10/10 180-Day |
TELIGEN ICD | Guidant Corporation St. Paul, MN 55112 |
Approval for: 1) the elevated pressure labeling modifications for TELIGEN ICD Models E103, E111, E102 and E110; and 2) the new 4-site header for TELIGEN ICD Models E103 and E111. |
| P960040/S238 11/19/10 Real-Time |
Prizm and Vitality Families | Boston Scientific CRM St. Paul, MN 55112 |
Approval for modifications to the software for the Latitude Inductive Communicator (Model 6481). |
| P970003/S110 11/5/10 135-Day |
VNS Therapy® System | Cyberonics, Inc. Houston, TX 77058 |
Approval to change the generator cleaning process. |
| P970003/S115 11/18/10 Real-Time |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Approval for changes to battery longevity design requirements and related labeling of battery longevity tables for the Model 102 and 102R Pulse Generators. |
| P970003/S116 11/23/10 Real-Time |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Approval for design modifications and associated labeling changes to the programming software, Model 250 Programming Software. |
| P970012/S071 11/10/10 135-Day |
Kappa 400 Family of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P970051/S063 11/24/10 Real-Time |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 | Approval for modifications to the printed circuit board (PCB) of the external CP810 Sound Processor. |
| P980016/S250 11/10/10 135-Day |
Capsure Family of Leads, Entrust, Gem, Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Secure, Virtuoso, and Virtuoso II Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P980022/S076 11/17/10 135-Day |
Continuous Glucose Monitoring System, Sof-Sensor MMT-7002 | Medtronic, Inc. Northridge, CA 91325 | Approval for the modifications of the coating process from the spin coating process to the slot coating process, and the adhesion promoter (AP) solution. |
| P980022/S086 11/1/10 Real-Time |
Continuous Glucose Monitoring System | Medtronic, Inc. Northridge, CA 91325 | Approval for a change to the CareLink® Pro (MMT-7335)-Therapy management software for diabetes, from version 3.0A to 3.0B. |
| P980035/S177 11/10/10 135-Day |
350 Series, Adapta, AT500, EnPulse, EnRhythm, Kappa 600/700/800/900, Relia, Sensia, Versa, and Sigma Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P980050/S050 11/10/10 135-Day |
CS-SVC Transvene Family of Leads, Jewel AF, and GEM III AT Family of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P990001/S072 11/10/10 135-Day |
Clarity, DA+ C-Series, DA+ T-Series, Diamond 3, Diamond II, Jade 3, Jade II, Ruby 3, Ruby II, Selection AFm, Topaz 3, Topaz II, Vita, and Vita 2 Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P990027/S015 11/30/10 180-Day |
Technolas Perfect Vision® 217z Zyoptix System for Personalized Vision Correction | Technolas Perfect Vision GmbH Munchen, Germany 80992 | Approval for the Advanced Nomogram Software Module as an upgrade to the existing software of the Technolas Perfect Vision® 217z Zyoptix System for Personalized Vision Correction. The Advanced Nomogram resides on a separate computer with the Zylink treatment calculation software, and it leaves all hardware components and the laser beam control software module unchanged. The Technolas Perfect Vision 217z Zyoptix System for Personalized Vision Correction with Advanced Nomogram Software Module is indicated for wavefront-guided laser assisted in-situ keratomileusis (LASIK): 1) for the reduction or elimination of myopia with sphere up to -7.00 D and cylinder up to -3.00 D and MRSE ≤7.50 D at the spectacle plane; 2) in patients with documented evidence of a change in manifest refraction of less than or equal to ±0.50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the pre-operative examination; and 3) in patients 21 years of age or older. |
| P990066/S037 11/5/10 135-Day |
GE Healthcare Senographe Digital Mammography System | GE Healthcare Waukesha, WI 53188 | Approval to replace the current image receptor/detector supplier. |
| P990081/S008 11/17/10 Special |
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for changes in quality controls to ensure the safety in the use of the device by: 1) adding a test to ensure appropriate stain intensity of the primary antibody at the bulk manufacturing stages; and 2) adding quality control testing steps at the raw material production and bulk manufacturing stages. |
| P000009/S040 11/26/10 180-Day |
Evia/Entois Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Atrial Capture Control and Ventricular Pacing Suppression features included in version 1002.U/1 programmer software for the Evia/Entois pulse generators. |
| P010012/S212 11/10/10 180-Day |
COGNIS CRT-D | Guidant Corporation St. Paul, MN 55112 |
Approval for: 1) the elevated pressure labeling modifications for COGNIS CRT-D Models N120, N118 and N119; and 2) the new 4 site-header for COGNIS CRT-D Model N120. |
| P010012/S258 11/19/10 Real-Time |
Contak and Renewal Families | Boston Scientific CRM St. Paul, MN 55112 |
Approval for modifications to the software for the Latitude Inductive Communicator (Model 6481). |
| P010015/S093 11/10/10 135-Day |
Attain Family of Leads, InSync, and InSync III Families of CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P010023/S006 11/5/10 180-Day |
Maxum System | Ototronix, LLC Houston, TX 77386 |
Approval for a new EO sterilization site for the packaged Implant Assembly. |
| P010025/S019 11/16/10 180-Day |
Selenia Dimensions 2D Full Field Digital Mammography System | Hologic, Inc. Bedford, MA 01730 |
Approval for additional Automatic Exposure Control (AEC) technique tables. The device, as modified, will be marketed under the trade name Selenia Dimensions 2D Full Field Digital Mammography System. |
| P010031/S206 11/10/10 135-Day |
Concerto, Concerto II, Consulta, InSync ICD, InSync Marquis, InSync Maximo, InSync II Marquis, Maximo II, InSync II Protect, InSync III Marquis, and InSync Sentry Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P010032/S034 11/19/10 Special |
Implantable Pulse Generator System | St. Jude Medical Plano, TX 75024 |
Approval for the addition of crimp rings in the strain reliefs of the external programming wand cable to improve reliability. |
| P010032/S035 11/17/10 Special |
Implantable Pulse Generator System | St. Jude Medical Plano, TX 75024 |
Approval for labeling changes that clarify the surgical procedures used to implant paddle leads. |
| P020003/S007 11/10/10 180-Day |
Saline Filled Testicular Prosthesis | Coloplast Corporation Minneapolis, MN 55411 | Approval for the change of the Saline Filled Testicular Prosthesis and the re-branding to “Torosa Testicular Prosthesis”. |
| P020016/S005 11/8/10 180-Day |
Walter Lorenz Total Temporomandibular Joint Replacement System | Biomet Microfixation, Inc. Jacksonville, FL 32218 | Approval for proposed labeling changes following the conclusion of the postmarket study for the Walter Lorenz Total Temporomandibular Joint Replacement System. |
| P030010/S006 11/5/10 180-Day |
Siemens Mammomat Inspiration DR Full Field Digital Mammography System | Siemens Medical Solution USA, Inc. Malvern, PA 19355 |
Approval for changing the OEM components (detector and image processing) developed by Lorad, the MAMMOMATNovation, to an FFDM system that is designed solely from components designed or specified by Siemens, the MAMMOMATInspiration. |
| P030036/S018 11/10/10 135-Day |
SelectSecure Family of Leads and Anchoring Sleeve Kit | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P040012/S032 11/8/10 135-Day |
ACCULINK™ Carotid Stent System | Abbott Vascular Temecula, CA 92590 | Approval for modifications to the stent laser manufacturing process. |
| P040021/S012 11/5/10 135-Day |
St. Jude Medical Biocor™, Bicor™ Supra, Epic™, and Epic™ Supra Heart Valves | St. Jude Medical St. Paul, MN 55117 |
Approval for removal of a final product quality inspection. |
| P040025/S011 11/23/10 Real-Time |
Olympic Cool-Cap® | Natus Medical, Inc. Seattle, WA 98108 |
Approval for an alternate power supply for the Olympic Cool-Cap System. |
| P040045/S014 11/18/10 135-Day |
VISTAKON® (senofilcon A) Contact Lenses | Vistakon – Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 | Approval for the implementation of an alternate method for visual inspection of raw materials for VISTAKON® (senofilconA) Contact Lenses, Clear and Visibility Tinted with UV Blocker. |
| P050012/S027 11/16/10 Real-Time |
DexCom Seven and Seven Plus Continuous Glucose Monitoring System | DexCom, Inc. San Diego, CA 92121 |
Approval for a reduction in standoff as well as addition of shock mounting on the receiver unit of the device. |
| P050023/S033 11/26/10 180-Day |
Evia/Entovis Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Atrial Capture Control and Ventricular Pacing Suppression features included in version 1002.U/1 programmer software for the Evia/Entois pulse generators. |
| P050033/S006 11/5/10 180-Day |
Hydrelle™ Dermal Filler | Anika Therapeutics, Inc. Bedford, MA 01730 |
Approval for a manufacturing site located in Bedford, Massachusetts. |
| P050048/S005 11/23/10 180-Day |
MONOLISA Anti-HBs EIA and MONOLISA Anti-HBs Calibrator Kit | Bio-Rad Laboratories Redmond, WA 98052 | Approval for a manufacturing site located at Bio-Rad Laboratories in Woodinville, Washington. |
| P060008/S061 11/16/10 180-Day |
TAXUS™ Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval of the post-approval study protocol. |
| P060031/S004 11/23/10 180-Day |
MONOLISA Anti-HBc EIA | Bio-Rad Laboratories Redmond, WA 98052 | Approval for a manufacturing site located at Bio-Rad Laboratories in Woodinville, Washington. |
| P060034/S005 11/23/10 180-Day |
MONOLISA Anti-HBc IgM EIA | Bio-Rad Laboratories Redmond, WA 98052 | Approval for a manufacturing site located at Bio-Rad Laboratories in Woodinville, Washington. |
| P060037/S009 11/3/10 180-Day |
Zimmer NexGen LPS-Flex Mobile & LPS Mobile Bearing Knee Systems | Zimmer, Inc. Warsaw, IN 46581 |
Approval for the addition of Prolong Highly Crosslinked Polyethylene tibial articular surfaces to the NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System. |
| P060039/S013 11/10/10 135-Day |
Attain StarFix Family of Leads | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
| P070001/S005 11/19/10 135-Day |
ProDisc C Total Disc Replacement | Synthes Spine West Chester, PA 19380 |
Approval for a change in the barrel blasting process. |
| P070008/S017 11/26/10 180-Day |
Evia/Entovis Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Atrial Capture Control and Ventricular Pacing Suppression features included in version 1002.U/1 programmer software for the Evia/Entois pulse generators. |
| P080006/S010 11/10/10 135-Day |
Attain Family of Leads | Medtronic, Inc. Mounds View, MN 55112 | Approval for implementation of a new release of traceability software. |
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 |
|---|---|---|---|
| N18033/S049 11/23/10 |
VISTAKON® (etafilcon A) Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 | Change in a quality control test method for the finished VISTAKON® (etafilcon A) contact lenses. |
| N18033/S050 11/10/10 |
VISTAKON® (etafilcon A) Contact Lenses, Clear and Visibility Tinted UV Blocker | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 | Implementation of two test methods for the identification of raw materials. |
| P790007/S027 11/19/10 |
Hancock® I Modified Orifice Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 | Addition of a quality control test for an incoming raw material. |
| P790007/S028 11/19/10 |
Hancock® I Modified Orifice Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 | Addition of a new tissue adapter. |
| P820003/S101 11/23/10 |
Disposable EPG Cover | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P830061/S058 11/23/10 |
Vitatron Crystaline Lead, Vitratron Excellence+ Lead, Vitatron Excellence PS+ Lead, Capsure SP Lead, Capsure Sense Lead, Capsure, and Capsure SP Novus Lead | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P840001/S167 11/10/10 |
Itrel 3 Implantable Neurostimulators & Restore Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Change to a new contract laboratory for inspection procedures. |
| P840001/S168 11/24/10 |
Itrel 3 Implantable Neurostimulator, Synergy Family of Implantable Neurostimulators, External Neurostimulators, and Restore Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Implementation of updated hardware and software for the barcode/optical character recognition labeler system as well as a process change pertaining to the upgraded labeler system. |
| P840064/S045 11/10/10 |
DISCOVISC®, VISCOAT®, DUOVISC® |
Alcon Research, Ltd. Fort Worth, Texas 76134 |
Expansion of the currently approved cleanroom (including an office area) and the addition of a new material lock for OVD manufacturing processes. |
| P850089/S071 11/23/10 |
CapSure Lead, STERx Tip Pacing Lead, CapSure Z Novus Lead, CapSure SP Novus Lead, Vitatron Impulse Lead, Vitatron Impulse II Lead, Vitatron Excellence S+ Lead, Vitatron Excellence SS+ Lead | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P860004/S142 11/3/10 |
Intrathecal Catheters and Catheter Revision Kit | Medtronic Neuromodulation Minneapolis, MN 55432 | The addition of a cleaning process to the manufacturing of introducer needles. |
| P860004/S143 11/24/10 |
SynchroMed II Infusion Pump | Medtronic Neuromodulation Minneapolis, MN 55432 | Implementation of updated hardware and software for the barcode/optical character recognition labeler system as well as a process change pertaining to the upgraded labeler system. |
| P870078/S012 11/19/10 |
Hancock® Porcine Bioprosthesis, Low Porosity Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 | Addition of a quality control test for an incoming raw material. |
| P870078/S013 11/19/10 |
Hancock® Porcine Bioprosthesis, Low Porosity Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 | The addition of a new tissue adapter. |
| P880006/S069 11/8/10 |
Sensolog/Dialog/ Regency Family of Pacemakers | St. Jude Medical Sylmar, CA 91392 |
Change in the adhesive mixing process used in pacemaker and CRT-P manufacturing. |
| P880086/S194 11/8/10 |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical Sylmar, CA 91392 |
Change in the adhesive mixing process used in pacemaker and CRT-P manufacturing. |
| P890003/S204 11/10/10 |
Prodigy SR | Medtronic, Inc. Mounds View, MN 55112 | Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis. |
| P890003/S205 11/19/10 |
Medtronic Model 2090 Programmer | Medtronic, Inc. Mounds View, MN 55112 | Restarting the production of the power supply at a previously approved vendor site. |
| P890003/S206 11/23/10 |
ECG Cable, CapSure VDD Leads, Service Kit-Pacemaker Repair Kit, Prodigy IPG, Brilliant S+ VDD Vitatron Lead | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P890047/S033 11/10/10 |
PROVISC® | Alcon Research, Ltd. Fort Worth, Texas 76134 |
Expansion of the currently approved cleanroom (including an office area) and the addition of a new material lock for OVD manufacturing processes. |
| P900061/S096 11/23/10 |
ACE Header, Lead end pin cap, Epicardial Patch Lead, Upsizing sleeve for Unipolar | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P910001/S038 11/10/10 |
CVX-300 Excimer Laser System | Spectranetics Corporation Colorado Springs, CO 80921 |
Addition of an alternate DI water supply. |
| P920015/S068 11/10/10 |
Sprint Quattro Single Coil IS-1/ DF-1, Active Fix Lead | Medtronic, Inc. Mounds View, MN 55112 | Transfer of the incoming inspection activities to MPROC Villalba and Juncos facilities. |
| P920015/S070 11/23/10 |
Lead adaptor, IS-1 Connector Port Pin Plug Kit, “Y” Adaptor/Extender Kit, Sprint Lead, Transvene DF1 Lead, Transvene RV Lead, Sprint Quattro Lead, Transvene SVC Lead, Transvene CS/SVC Lead, Subcutaneous Lead, Tunneling Tool, Transvene SubQ Lead | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P930014/S046 11/23/10 |
AcrySof® IQ Toric Intraocular Lenses | Alcon Research Ltd. Fort Worth, TX 76134 |
Software modification to the Manual Long (low diopter) Wet Aberrometer. |
| P930029/S027 11/23/10 |
RF Marinr Catheter, RF Marinr NTC Catheter, 5F RF Marinr Catheter, RF Conductr Catheter, RF Enhancer II Ablation Catheter, RF Contactr Catheter, Conductr Self-Ref, Atakr II | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P930039/S046 11/23/10 |
CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, Vitatron Pirouet+ Lead, Vitatron Crystaline Lead | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P950024/S026 11/23/10 |
CapSure Epicardial Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P960009/S099 11/10/10 |
Activa RC Implantable Neurostimulators & Soletra Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Change to a new contract laboratory for inspection procedures. |
| P960009/S100 11/24/10 |
Soletra Neurostimulator, Kinetra Neurostimulator, Activa Family of Neurostimulators, and External Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 | Implementation of updated hardware and software for the barcode/optical character recognition labeler system as well as a process change pertaining to the upgraded labeler system. |
| P960042/S022 11/10/10 |
SLS II Laser Sheath | Spectranetics Corporation Colorado Springs, CO 80921 |
Addition of an alternate DI water supply. |
| P970004/S095 11/2/10 |
InterStim II Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 | Change to the test specification limits of an existing final functional test. |
| P970004/S096 11/10/10 |
InterStim Implantable Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 | Change to a new contract laboratory for inspection procedures. |
| P970004/S097 11/24/10 |
InterStim Neurostimulator and InterStim II Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 | Implementation of updated hardware and software for the barcode/optical character recognition labeler system as well as a process change pertaining to the upgraded labeler system. |
| P970012/S075 11/10/10 |
Kappa 400 DR IPG, Kappa 400 SR IPG | Medtronic, Inc. Mounds View, MN 55112 | Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis. |
| P970012/S076 11/23/10 |
Kappa 400 IPG | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P970013/S037 11/8/10 |
Microny Family of Pacemakers | St. Jude Medical Sylmar, CA 91392 |
Change in the adhesive mixing process used in pacemaker and CRT-P manufacturing. |
| P970020/S058 11/1/10 |
MULTI-LINK Family of Coronary Stent Systems | Abbott Vascular Temecula, CA 92590 | Discontinuation of the quarterly pyrogen testing of the above named pre- and post-E-beam sterilized products. |
| P970021/S031 11/23/10 |
GYNECARE THERMA- CHOICE® III Uterine Balloon Therapy System | ETHICON Women’s Health and Urology Somerville, NJ 08876 | Change the extrusion process location of two components. |
| P970031/S030 11/19/10 |
Freestyle® Aortic Root Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Addition of a quality control test for an incoming raw material. |
| P970031/S031 11/19/10 |
Freestyle® Aortic Root Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Addition of a new tissue supplier. |
| P980003/S026 11/19/10 |
CircuCool Pump | Boston Scientific Corporation San Jose, CA 05134 |
Retrospective outsourcing of components by a supplier. |
| P980016/S261 11/10/10 |
Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR, Virtuoso ICDs | Medtronic, Inc. Mounds View, MN 55112 | Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis. |
| P980016/S262 11/10/10 |
Secura ICD: D224DRG, D224VRC; Virtuoso II ICD: D274DRG, D274VRC; Maximo II ICD: D284DRG, D284VRC | Medtronic, Inc. Mounds View, MN 55112 | Implementation of updated hardware and software for the barcode/optical character recognition labeler system used to identify integrated circuit component wafers at your hybrid supplier. |
| P980016/S263 11/23/10 |
CapSure Lead, Marquis ICD, Maximo ICD, Intrinsic 30/Intrinsic ICD, EnTrust ICD, Virtuoso ICD, Secura ICD, Virtuoso II ICD, Maximo II ICD | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P980022/S088 11/9/10 |
Continuous Glucose Monitoring System Sof-Sensor™ Glucose Sensor MMT-7003 | Medtronic, Inc. Northridge, CA 91325 | Change to extend rinse time for the Sof-Sensor™ Glucose Sensor MMT-7003. |
| P980035/S189 11/10/10 |
Kappa 600/700, 650, 800/900, Sigma, Medtronic 350, Enpulse, Adapta/Versa/ Sensia, Relia IPGs | Medtronic, Inc. Mounds View, MN 55112 | Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis. |
| P980035/S190 11/10/10 |
Adapta, Sensia, Versia IPGs: ADD01, ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, ADSR01, ADSR03, ADSR06, ADVDD01, SED01, SEDR01, SEDRL1, SES01, SESR01 and VEDR01; EnRhythm IPG: P1501DR; Relia IPGs: REDR01, RED01, REVDD01, RESR01, RES01 | Medtronic, Inc. Mounds View, MN 55112 | Implementation of updated hardware and software for the barcode/optical character recognition labeler system used to identify integrated circuit component wafers at your hybrid supplier. |
| P980035/S191 11/23/10 |
Adapta/Sensia/ Versa IPG, AT500 IPG, 350 Series, EnRhythm IPG, EnPulse IPG, Kappa 700 IPG, Kappa 800 IPG, Kappa 900 IPG, Relia IPG, Sigma IPG | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P980043/S028 11/19/10 |
Hancock® I Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Addition of a quality control test for an incoming raw material. |
| P980043/S029 11/19/10 |
Hancock® I Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Addition of a new tissue supplier. |
| P980050/S055 11/23/10 |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P990001/S077 11/10/10 |
C-series IPG, T-series IPG, Dema IPG (includes Clarity DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita 2 DDDR) | Medtronic, Inc. Mounds View, MN 55112 | Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis. |
| P990001/S078 11/23/10 |
Clarity IPG, Vitatron DA+ C-Series IPG, Diamond 3 IPG, Jade 3 IPG, Ruby 3 IPG, Vitatron DA+ T-Series IPG, Topaz 3 IPG, Vita 2 IPG, Vista IPG | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P990020/S042 11/5/10 |
Medtronic Vascular AneuRx AAAdvantage Stent Graft System | Medtronic, Inc. Santa Rosa, CA 95403 | The addition of an alternate automatic method for one of the manufacturing processes. |
| P990023/S010 11/10/10 |
CELLUGEL® | Alcon Research, Ltd. Fort Worth, Texas 76134 |
Expansion of the currently approved cleanroom (including an office area) and the addition of a new material lock for OVD manufacturing processes. |
| P990040/S014 11/10/10 |
TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System | Codman & Shurtleff, Inc. Raynham, MA 02767 | Change in: 1) supplier of the Ethiodized Oil component of the n-BCA Liquid Embolic System; and 2) the sterilization method for the Ethiodized Oil. |
| P990064/S035 11/19/10 |
Mosaic® Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Addition of a quality control test for an incoming raw material. |
| P990064/S036 11/19/10 |
Mosaic® Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Addition of a new tissue supplier. |
| P000014/S022 11/16/10 |
Vitros Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 | Completion of the relocation of equipment to the new manufacturing site of Pencoed, South Wales. |
| P000037/S021 11/8/10 |
On-X® Prosthetic Heart Valve | On-X Life Technologies, Inc. Austin, TX 78752 |
Use of additional manufacturing equipment at the Anderson Lane facility. |
| P000044/S025 11/16/10 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator; VITROS Immunodiagnostic Products HBsAg Confirmatory Kit | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 | Completion of the relocation of equipments to the new manufacturing site of Pencoed, South Wales. |
| P010015/S101 11/10/10 |
InSync CRT-P | Medtronic, Inc. Mounds View, MN 55112 | Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis. |
| P010015/S102 11/10/10 |
Attain Leads | Medtronic, Inc. Mounds View, MN 55112 | Transfer of the incoming inspection activities to MPROC Villalba and Juncos facilities. |
| P010015/S103 11/23/10 |
Attain Lead, InSync CRT-P, InSync III CRT-P | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P010031/S217 11/10/10 |
Concerto II, Consulta, Maximo II, and Concerto Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis. |
| P010031/S218 11/10/10 |
Consulta CRT-D, Concerto II CRT-D; Maximo II CRT-D |
Medtronic, Inc. Mounds View, MN 55112 | Implementation of updated hardware and software for the barcode/optical character recognition labeler system used to identify integrated circuit component wafers at your hybrid supplier. |
| P010031/S219 11/23/10 |
InSync III Marquis CRT-D, InSync II Marquis CRT-D, InSync Sentry CRT-D, InSync Maximo CRT-D, Concerto CRT-D, Consulta CRT-D, Concerto II CRT-D, Maximo II CRT-D | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P020009/S067 11/19/10 |
Express 2™ Monorail™ and Over-the-Wire Coronary Stent Systems | Boston Scientific, Corporation Maple Grove, MN 55311 | Change to product family grouping for the purposes of microbiological sample designation at the Maple Grove manufacturing facilities for pre-sterile product monitoring activities. |
| P020047/S026 11/1/10 |
MULTI-LINK VISION® Family of Coronary Stent Systems | Abbott Vascular Temecula, CA 92590 | Discontinuation of the quarterly pyrogen testing of pre- and post-E-beam sterilized products. |
| P020052/S007 11/5/10 |
Response™ CV Cardioversion Electrophysiology Catheter with Lumen | St. Jude Medical, Inc. Minnetonka, MN 55345 |
Changes to the wire-to-ring and anchor wire brazing process. |
| P030009/S047 11/1/10 |
Integrity Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 | Change to the balloon subassembly manufacturing process. |
| P030009/S048 11/17/10 |
Integrity Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 | Alternative system for in-process dimensional measurements. |
| P030017/S110 11/17/10 |
Precision Spinal Cord Stimulator System (SCS) | Boston Scientific Valencia, CA 91355 | Addition of an alternate supplier for the Printed Circuit Board (PCB) used in the assembly of SCS Chargers. |
| P030024/S013 11/16/10 |
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 | Relocation of equipment to the new manufacturing site of Pencoed, South Wales. |
| P030026/S020 11/16/10 |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 | Relocation of equipment to the new manufacturing site of Pencoed, South Wales. |
| P030028/S002 11/23/10 |
Artisan™ Myopia Phakic IOL | Ophtec USA, Inc. Boca Raton, FL 33487 | Shortening of Ethylene Oxide degassing phase process and an additional sterilization configuration. |
| P030035/S074 11/8/10 |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical Sylmar, CA 91392 |
Change in the adhesive mixing process used in pacemaker and CRT-P manufacturing. |
| P030036/S024 11/23/10 |
SelectSecure Lead, Anchoring Sleeve Kit | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P040012/S035 11/1/10 |
ACCULINK™ Carotid Stent System | Abbott Vascular Temecula, CA 92590 | Discontinuation of the quarterly pyrogen testing of pre- and post-E-beam sterilized products. |
| P040016/S064 11/19/10 |
VeriFLEX™ Monorail™ and Over-the-Wire Coronary Stent Systems | Boston Scientific, Corporation Maple Grove, MN 55311 | Change to product family grouping for the purposes of microbiological sample designation at the Maple Grove manufacturing facilities for pre-sterile product monitoring activities. |
| P040020/S028 11/23/10 |
AcrySof® IQ ReSTOR® Intraocular Lenses | Alcon Research Ltd. Fort Worth, TX 76134 | Software modification to the Manual Long (low diopter) Wet Aberrometer. |
| P040037/S031 11/24/10 |
Gore VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 | Duplicate manufacturing process at the Medical Central Building at the Flagstaff facility. |
| P040037/S032 11/24/10 |
Gore VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 | Modify a pressure vessel used in the heparin coating process. |
| P040045/S017 11/10/10 |
VISTAKON® (senofilcon A) Contact Lenses, Clear and Visibility Tinted with UV Blocker | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 | Implementation of test methods for the identification of raw materials, for the VISTAKON® (senofilcon A) Contact Lens materials. |
| P050020/S026 11/18/10 |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Laboratories Alameda, CA 94502 |
Change to the number of Sensors Delivery Units retained as reserve samples. |
| P050020/S027 11/23/10 |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Laboratories Alameda, CA 94502 | Change of the FreeStyle Test Strips from a manual to an automatic process. |
| P050020/S028 11/23/10 |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Laboratories Alameda, CA 94502 | New shipping configuration for the Navigator Sensor Delivery Unit (SDU). |
| P050020/S029 11/23/10 |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Laboratories Alameda, CA 94502 | Change to verify the presence and location of adhesive channels in the FreeStyle Test Strips. |
| P050020/S030 11/18/10 |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Laboratories Alameda, CA 94502 | Modification to the process for coating Freestyle Test Strips with mediator. |
| P050020/S031 11/23/10 |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Laboratories Alameda, CA 94502 | Change in the cleaning procedure of the reactors used to make the nPBI mediator chemical used in the FreeStyle Test Strips and the time frame in which this cleaning process takes place. |
| P060039/S018 11/10/10 |
Attain Starfix Lead | Medtronic, Inc. Mounds View, MN 55112 | Transfer of the incoming inspection activities to MPROC Villalba and Juncos facilities. |
| P060039/S019 11/23/10 |
Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P070007/S023 11/5/10 |
Medtronic Vascular Talent Thoracic Stent Graft System | Medtronic, Inc. Santa Rosa, CA 95403 | Addition of an alternate automatic method for one of the manufacturing processes. |
| P070015/S050 11/8/10 |
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) | Abbott Vascular Santa Clara, CA 95054 | Modification of a device packaging quality control test. |
| P070015/S051 11/8/10 |
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) | Abbott Vascular Santa Clara, CA 95054 | Increase of a retesting interval. |
| P070027/S023 11/5/10 |
Medtronic Vascular Talent Abdominal Stent Graft System | Medtronic, Inc. Santa Rosa, CA 95403 | Addition of an alternate automatic method for one of the manufacturing processes. |
| P080006/S016 11/10/10 |
Attain Ability LV Lead | Medtronic, Inc. Mounds View, MN 55112 | Transfer of the incoming inspection activities to MPROC Villalba and Juncos facilities. |
| P080006/S017 11/23/10 |
Attain Ability Lead | Medtronic, Inc. Mounds View, MN 55112 | Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers. |
| P090018/S008 11/23/10 |
Esteem | Envoy Medical Corporation Saint Paul, MN 55110 |
Change in the USB cable assembly, and the supplier for the cable, to be used with the Esteem programmer. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 66
Summary of PMA Originals Under Review
Total Under Review: 92
Total Active: 36
Total On Hold: 56
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 640
Total Active: 416
Total On Hold: 224
Number Greater Than 180 Days: 11
Summary of All PMA Submissions Received
Originals: 2
Supplements: 80
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 66
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 166.1
FDA Time: 106.6 Days MFR Time: 59.5 Days
