FDA releases November 2011 PMAs

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