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FDA releases October PMAs

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The Food & Drug Administration released a list of pre-market approvals granted in October:

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P100016
10/19/10		 EC-3 Intraocular Lens (IOL) and
EC-3 Precision Aspheric Lens (PAL) IOL		 Aaren Scientific, Inc.
Ontario, CA
91761		 Approval for the EC-3 Intraocular Lens (IOL) and
EC-3 Precision Aspheric Lens (PAL) IOL. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N12159/S026
10/27/10
Real-Time 		Surgical Absorbable Hemostat Ethicon, Inc.
Somerville, NJ
08876		 Approval for the addition of a non-woven version of Surgicel.
N18286/S020
10/19/10
Special 		Gelfoam Absorbable Gelatin Sponge Pfizer, Inc.
New York, NY
10017		 Approval for an update to the labeling to include the contraindication: “Do not use GELFOAM Absorbable Gelatin Sponge in patients with known allergies to porcine collagen.”
P790017/S106
10/19/10
135-Day 		Gruntzig Dilaca Balloon Dilatation Catheters Medtronic Vascular
Santa Rosa, CA
95403		 Approval for the addition of a new ultraviolet curing machine.
P850022/S017
10/15/10
180-Day 		OrthoPak Non-Invasive Bone Growth Stimulator System & SpinalPak Non-Invasive Spine Fusion Stimulator System EBI, L.P.
Parsippany, NJ
07054		 Approval for changes to the hardware, software, components, and specifications
Of the device.
P860004/S126
10/6/10
Special 		SynchroMed, SynchroMed EL and SynchroMed II Implantable Infusion Systems Medtronic Neuromodulation
Minneapolis, MN
55432		 Approval for labeling changes to the SynchroMed, SynchroMed EL and SynchroMed II Implantable Infusion Systems to specifically reference Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain, and Prialt (preservative-free
ziconotide sterile solution) for the management of severe chronic pain, identify the maximum concentration for Infumorph, Prialt and Lioresal that can be delivered.
P860004/S140
10/7/10
Special 		SynchroMed, SynchroMed EL and SynchroMed II Implantable Infusion Systems Medtronic Neuromodulation
Minneapolis, MN
55432		 Approval for labeling changes to the SynchroMed, SynchroMed EL and SynchroMed II Implantable Infusion Systems to include cephalad migration of catheter fragments aspart of the adverse event summaries.
P880006/S068
10/1/10
Real-Time 		Sensolog/Dialog/ Regency Family of Pacemakers St. Jude Medical, CRMD
Sylmar, CA
91342		 Approval for the Merlin PCS Software Model 3330 version 10.1.1.2.
P880086/S192
10/1/10
Real-Time 		Affinity/Integrity/ Victory Family of Pacemakers St. Jude Medical, CRMD
Sylmar, CA
91342		 Approval for the Merlin PCS Software Model 3330 version 10.1.1.2.
P890003/S191
10/19/10
180-Day 		Carelink DDMA Software, CareLink Monitor Medtronic, Inc.
Mounds View, MN
55112		 Approval for modifications to the Medtronic EnRhythm™ pulse generators and Entrust (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) Programmer Application Software Model 9987 (Version 7.2), Model 2491 Device Data Management Application (DDMA) (part of Model 2490G Carelink Monitor System), firmware, and the post sterilization manufacturing test software.
P910023/S248
10/1/10
Real-Time 		Cadence Family of ICDs St. Jude Medical, CRMD
Sylmar, CA
91342		 Approval for the Merlin PCS Software Model 3330 version 10.1.1.2.
P950005/S030
10/1/10
180-Day 		Celsius Catheter, Non-Temperature Sensing Ablation Catheters, Interface Cables Biosense Webster, Inc.
Diamond Bar, CA
91765		 Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico.
P950032/S060
10/26/10
Real-Time 		Apligraf (Graftskin) Organogenesis, Inc.
Canton, MA
01021		 Approval for the introduction of keratinocyte cell strain (HEP074) into the manufacture of Apligraf.
P960040/S224
10/15/10
Real-Time 		Teligen Pulse Generators Boston Scientific Cardiac Rhythm Management
St. Paul, MN
55112		 Approval for the addition of second source diode suppliers (ST Micro and Minco Technology Labs) for the HCVM and SOM used in the Cognis and Teligen pulse generators.
P970013/S035
10/1/10
Real-Time 		Microny Family of Pacemakers St. Jude Medical, CRMD
Sylmar, CA
91342		 Approval for the Merlin PCS Software Model 3330 version 10.1.1.2.
P980016/S237
10/19/10
180-Day 		Enrythm IPG Medtronic, Inc.
Mounds View, MN
55112		 Approval for modifications to the Medtronic EnRhythm™ pulse generators and Entrust (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) Programmer Application Software Model 9987 (Version 7.2), Model 2491 Device Data Management Application (DDMA) (part of Model 2490G Carelink Monitor System), firmware, and the post sterilization manufacturing test software.
P980016/S255
10/29/10
Real-Time 		Concerto H, Consulta, Secura,
Virtuoso, Maximo, Adapta, Relia,
Sensia, and Versa		 Medtronic, Inc.
Mounds View, MN
55112		 Approval for the design changes to X7R-0805 Multilayer Ceramic Capacitors (XC194 and XC291).
P980018/S009
10/7/10
Real-Time 		HercepTest™ Kit
 		 Dako Denmark A/S
Glostrup, Denmark
DK-2600		 Approval for a change in the formulation of the HercepTest™ Epitope Retrieval Solution.
P980018/S010
10/20/10
Panel 		HercepTest™ Kit Dako Denmark A/S
Glostrup, Denmark
DK-2600		 Approval for the HercepTest™ Kit. The device is indicated for in vitro diagnostic use. HercepTest™ is a semi-quantitative immunocytochemi-cal assay to determine HER2 protein overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HercepTest™ is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered (see Herceptin® package insert).
P980022/S081
10/13/10
180-Day 		Paradigm® REAL-Time System Medtronic, Inc.
Northridge, CA
91325		 Approval for a software change to the Paradigm REAL-Time Revel Insulin Pump (Models MMT-523, MMT-723, MMT-523K, MMT-723K), version 2.4A.
P980022/S083
10/6/10
Real-Time 		Medtronic Minimed Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA
91325		 Approval for minor modification to the design of the Paradigm REAL-Time Pump case (Models MMT-522, MMT-522K, MMT-523, MMT-523K) to allow for a “two shot” molding technology for the manufacture of the main case by a new supplier.
P980022/S089
10/13/10
Real-Time 		Paradigm® REAL-Time Revel™ Insulin Pump Medtronic, Inc.
Northridge, CA
91325		 Approval for the trade name change for Paradigm REAL-Time Revel Insulin Pump (Models MMT-523, MMT-723, MMT-523K, MMT-723K). The new trade name for these insulin pumps is Paradigm® REAL-Time Revel™ insulin pump.
P980035/S166
10/19/10
180-Day 		Entrust ICD Family Medtronic, Inc.
Mounds View, MN
55112		 Approval for modifications to the Medtronic EnRhythm™ pulse generators and Entrust (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) Programmer Application Software Model 9987 (Version 7.2), Model 2491 Device Data Management Application (DDMA) (part of Model 2490G Carelink Monitor System), firmware, and the post sterilization manufacturing test software.
P980035/S182
10/29/10
Real-Time 		Concerto H, Consulta, Secura,
Virtuoso, Maximo, Adapta, Relia,
Sensia, and Versa		 Medtronic, Inc.
Mounds View, MN
55112		 Approval for the design changes to X7R-0805 Multilayer Ceramic Capacitors (XC194 and XC291).
P980044/S012
10/19/10
135-Day 		SUPARTZ® Smith & Nephew, Inc.
Memphis, TN
38116		 Approval for a change in the plastic syringe barrel mold.
P990021/S002
10/13/10
Real-Time 		630 PDT Laser AngioDynamics
Latham, NY
12110		 Approval for the use of an alternative source of laser diode and modification of the thermal management of the device.
P990025/S025
10/1/10
180-Day 		NaviStar Catheter, Interface Cables Biosense Webster, Inc.
Diamond Bar, CA
91765		 Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico.
P990034/S018
10/6/10
Special 		IsoMed Implantable Infusion Systems Medtronic Neuromodulation
Minneapolis, MN
55432		 Approval to:
1) update the labeling for these devices to specifically reference Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain; and 2) to add language to identify the maximum concentration for Infumorph that can be delivered through the IsoMed Implantable Infusion Systems.
P990034/S020
10/7/10
Special 		SynchroMed, SynchroMed EL and SynchroMed II Implantable Infusion Systems Medtronic Neuromodulation
Minneapolis, MN
55432		 Approval to update the labeling for these devices to specifically state cephalad migration of catheter fragments as part of the adverse event summaries in the devices’ Information for Prescribers Manuals and User Manuals.
P990040/S013
10/8/10
135-Day 		TFUFILL® n-Butyl Cyanoacrylate
(n-BCA) Liquid Embolic System		 Codman & Shurtleff, Inc.
Raynham, MA
02767		 Approval to change the chemical composition testing supplier.
P990071/S010
10/1/10
180-Day 		Interface Cables Biosense Webster, Inc.
Diamond Bar, CA
91765		 Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico.
P000008/S020
10/8/10
Special 		LAP-BAND® Adjustable Gastric Banding (LAGB) System Allergan, Inc.
Goleta, CA
93117		 Approval to modify the Directions for Use to add cautionary statements regarding how the needle is to be inserted into the Access Port septum to prevent damage to the Access Port.
P000029/S067
10/26/10
180-Day 		Deflux Injectable Gel Oceana Therapeutics, Inc.
Edison, NJ
08817		 Approval to extend the shelf life to 24 months after manufacture.
P010012/S244
10/15/10
Real-Time 		Cognis Pulse Generators Boston Scientific Cardiac Rhythm Management
St. Paul, MN
55112		 Approval for the addition of second source diode suppliers (ST Micro and Minco Technology Labs) for the HCVM and SOM used in the Cognis and Teligen pulse generators.
P010029/S010
10/25/10
135-Day 		EUFLEXXA (1% Sodium Hyaluronate) Ferring Pharmaceuticals, Inc.
Parsippany, NJ
07054		 Approval for addition of new equipment used in the manufacturing process to increase finished product lot capacity 3 – 4 fold.
P010031/S211
10/29/10
Real-Time 		Concerto H, Consulta, Secura,
Virtuoso, Maximo, Adapta, Relia,
Sensia, and Versa		 Medtronic, Inc.
Mounds View, MN
55112		 Approval for the design changes to X7R-0805 Multilayer Ceramic Capacitors (XC194 and XC291).
P010068/S020
10/1/10
180-Day 		Celsius DS Catheter, NaviStar DS Catheter, Interface Cables Biosense Webster, Inc.
Diamond Bar, CA
91765		 Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico.
P020004/S053
10/8/10
135-Day 		Gore Excluder® AAA Endoprosthesis, Graft WL Gore & Associates, Inc.
Flagstaff, AZ
86001		 Approval for modifications to settings and associated software to the laser/torque, olive bonding, transition forming, and torque bump stations.
P020045/S029
10/29/10
180-Day 		Freezor Xtra/MAX Surgical Cryoablation Devices and CryoConsole Systems Applied Physics
Galisteo, NM
87540		 Approval for a manufacturing site located at Medtronic CryoCath LP in Point Claire, Quebec for warehousing and performing incoming inspections.
P030009/S042
10/19/10
180-Day 		Driver & Microdriver Coronary Stent Systems Medtronic CryoCath LP
Galisteo, NM
87540		 Approval for a manufacturing site located at Medtronic CryoCath LP in Point Claire, Quebec to warehouse and perform incoming inspections.
P030010/S005
10/6/10
180-Day 		Siemens Mammomat Novation DR Full Field Digital Mammography System Siemens Medical Solutions USA, Inc.
Malvern, PA
19355		 Approval for Siemens own image processing algorithms on the Mammomat Novation DR Full Field Digital Mammography System.
P030011/S008
10/26/10
180-Day 		SynCardia Temporary Total Artificial Heart SynCardia Systems, Inc.
Tucson, AZ
85713		 Approval of the post-approval study protocol.
P030031/S028
10/1/10
180-Day 		Celsius ThermoCool Catheter, NaviStar ThermoCool Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765		 Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico.
P030035/S072
10/1/10
Real-Time 		Frontier/Frontier II Family of CRT-Ps St. Jude Medical, CRMD
Sylmar, CA
91342		 Approval for the Merlin PCS Software Model 3330 version 10.1.1.2.
P030054/S167
10/1/10
Real-Time 		Epic HF/Atlas+ HF Family of CRT-Ds St. Jude Medical, CRMD
Sylmar, CA
91342		 Approval for the Merlin PCS Software Model 3330 version 10.1.1.2.
P040005/S005
10/20/10
180-Day 		HER 2 FISH pharmDx™ Kit Dako Denmark A/S
Glostrup, Denmark
DK-2600		 Approval for the HER2 FISH pharmDx™ Kit. The device is indicated for in vitro diagnostic use. The HER2 FISH pharmDx™ Kit is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens and FFPE specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HER2 FISH pharmDx™ Kit is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered (See Herceptin® package insert).
P040033/S016
10/13/10
Special 		Birmingham Hip Resurfacing (BHR) System Smith & Nephew Orthopaedics
Memphis, TN
38116		 Approval for revisions to the physician and patient labeling.
P040036/S021
10/1/10
180-Day 		NaviStar ThermoCool Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765		 Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico.
P040040/S014
10/1/10
180-Day 		AMPLATZER Muscular VSD Occluder AGA Medical, Inc.
Plymouth, MN
55442		 Approval of the post-approval study protocol.
P040044/S033
10/22/10
Real-Time 		Mynx® Cadence™ Vascular Closure Device AccessClosure, Inc.
Mountain View, CA
94043		 Approval for removing the Inner Cartridge assembly, reducing the Advancer Tube markers to one and adding a shuttle stop feature.
P050034/S001
10/7/10
180-Day 		Implantable Miniature Telescope VisionCare Ophthalmic Technologies, Inc.
Saratoga, CA
95070		 Approval of the post-approval study protocol.
P050034/S002
10/13/10
180-Day 		Implantable Miniature Telescope VisionCare Ophthalmic Technologies, Inc.
Saratoga, CA
95070		 Approval of the post-approval study protocol.
P050050/S001
10/8/10
180-Day 		Scandinavian Total Ankle Replacement System (STAR Ankle) Small Bone Innovations, Inc.
Morrisville, PA
19067		 Approval of the post-approval study protocol.
P060006/S013
10/4/10
135-Day 		Express® SD Renal Monorail® Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Approval for an alternate stent finishing process using an automated system in place of the current manual system.
P060033/S051
10/19/10
135-Day 		Endeavor Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular
Santa Rosa, CA
95403		 Approval for the addition of a new ultraviolet curing machine.
P060037/S013
10/20/10
Special 		Zimmer NexGen® LPS-Flex Mobile and LPS-Mobile Bearing Knee Systems Zimmer, Inc.
Warsaw, IN
46581		 Approval for the addition of an inspection step for the Fluted Stem Mobile Tibial Baseplate engraved line feature.
P060040/S012
10/27/10
Real-Time 		Thoratec HeartMate II LVAS Thoratec Corporation
Pleasanton, CA
94588		 Approval for a modification to the HeartMate II patient power cable connectors.
P060040/S013
10/8/10
Special 		Thoratec HeartMate II LVAS Thoratec Corporation
Pleasanton, CA
94588		 Approval for revised Operator Manual and Patient Handbook labeling for the device.
P070007/S021
10/26/10
180-Day 		Talent Thoracic Stent Graft with Captivia Delivery System Medtronic Vascular
Santa Rosa, CA
95403		 Approval for two new longer length proximal main stent grafts, the new Captivia delivery system, and a new sterilization site.
P070014/S014
10/18/10
180-Day 		LifeStent Vascular Stent Systems Bard Peripheral Vascular, Inc.
Tempe, AZ
85280		 Approval of the post-approval study protocol.
P070014/S018
10/14/10
180-Day 		LifeStent and LifeStent XL Vascular Stent Systems Bard Peripheral Vascular, Inc.
Tempe, AZ
85280		 Approval for a change in labeling that updates the Instructions for Use and the Patient Information Brochure to include the most recent clinical data up to 3 years.
P070015/S031
10/29/10
135-Day 		XIENCE V® Everolimus Eluting Coronary Stent Systems and PROMUS™ Everolimus-Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92590		 Approval for the addition of an alternate syringe in a manufacturing process.
P080014/S003
10/6/10
Real-Time 		Cervista® HPV HR Genfind DNA Extraction Kit Hologic, Inc.
Marlborough, MA
01752		 Approval for several changes to the Invader Call Reporter and Cervista HPV HR software on the separate CDs with new part numbers.
P090003/S003
10/4/10
135-Day 		Express® LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Approval for an alternate stent finishing process using an automated system in place of the current manual system.

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
P790017/S110
10/27/10 		Gruntzig Dilaca Balloon Dilatation Catheters Medtronic Vascular
Santa Rosa, CA
95403		 Transfer of post sterilization inspections to an alternate site.
P810046/S240
10/15/10 		Voyager® NC Coronary Dilatation Catheter Abbott Vascular, Inc.
Santa Clara, CA
95054		 Change to the methodology for sterilization dose audits.
P820060/S025
10/20/10 		AxSYM AFP Abbott Laboratories
Abbott Park, IL 60064		 Modification to a common accessory for AxSYM assays.
P830061/S057
10/29/10 		CapSure and Vitatron Chrystaline Drug-Eluting Defibrillator Electrode Medtronic, Inc.
Mounds View, MN
55112		 Addition of an alternate supplier of conductor coils.
P840001/S164
10/1/10 		Restore® Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432		 Addition of an alternate vendor for the printed wiring boards (PWBs) and manufacturing changes for PWB components.
P840001/S165
10/14/10 		Restore® Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432		 Additional supplier for hybrid components and to qualify two suppliers to perform surrogate inspections.
P850089/S070
10/29/10 		CapSure Drug-Eluting Permanent Defibrillator Electrode Medtronic, Inc.
Mounds View, MN
55112		 Addition of an alternate supplier of conductor coils.
P860004/S139
10/1/10 		SynchroMed® Drug Pumps Medtronic Neuromodulation
Minneapolis, MN
55432		 Addition of an alternate vendor for the printed wiring boards (PWBs) and manufacturing changes for PWB components.
P860057/S070
10/27/10 		Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences
Irvine, CA
92614		 Expansion of Clean Room #2 at the Changi, Singapore Manufacturing facility.
P890003/S200
10/8/10 		CareLink® Programmer Medtronic, Inc.
Mounds View, MN
55112		 Change to the method of data entry for creating product labels.
P890003/S203
10/29/10 		CapSure Implantable Pulse Generator Medtronic, Inc.
Mounds View, MN
55112		 Addition of an alternate supplier of conductor coils.
P910001/S037
10/15/10 		Spectranetics ELCA® Excimer Laser Coronary Atherectomy Catheters Spectranetics Corporation
Colorado Springs, CO
80921		 Change to the label printing process.
P910007/S020
10/20/10 		AxSYM Total PSA Abbott Laboratories
Abbott Park, IL 60064		 Modification to a common accessory for AxSYM assays.
P910023/S250
10/19/10 		Atlas II, Atlas II+, Atlas+, Epic+,
Epic II+,
Current RF, Current+,
Current Accel, and Fortify ICDs/
CRT-Ds		 St. Jude Medical
Sunnyvale, CA
94086		 Extension of primer dwell time from 24 to 72 hours.
P910023/S251
10/29/10 		Cadence Family of ICDs St. Jude Medical, Inc.
Sylmar, CA
91392		 Modifications to the automated manufacturing tests (ATE).
P920015/S067
10/29/10 		Sprint Quattro Steroid-Eluting Pacing Lead Medtronic, Inc.
Mounds View, MN
55112		 Addition of an alternate supplier of conductor coils.
P930039/S045
10/29/10 		CapSure Drug-Eluting Permanent Defibrillator Electrode Medtronic, Inc.
Mounds View, MN
55112		 Addition of an alternate supplier of conductor coils.
P950034/S034
10/7/10 		Seprafilm® Adhesion Barrier Genzyme Corp.
Framingham, MA
01701		 New cleaning schedule for equipment used in manufacturing of the device.
P950034/S035
10/26/10 		Seprafilm® Adhesion Barrier Genzyme Corp.
Framingham, MA
01701		 Change in manufacturing sites.
P960006/S027
10/20/10 		Flextend and Flextend 2 Extendable/ Retractable Endocardial Pacing Leads Boston Scientific Corporation
St. Paul, MN
55112		 Change in classification of the product families for elution characterization sampling.
P960009/S096
10/1/10 		Activa® Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432		 Addition of an alternate vendor for the printed wiring boards (PWBs) and manufacturing changes for PWB components.
P960009/S097
10/14/10 		Activa® Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432		 Additional supplier for hybrid components and to qualify two suppliers to perform surrogate inspections.
P960040/S237
10/8/10 		Vitality, Confient, Teligen Families of ICDs Boston Scientific Corporation
St. Paul, MN
55112		 Addition of a supplier for a capacitor component.
P970003/S114
10/13/10 		VNS Therapy System Cyberonics, Inc
Houston, TX
77058		 An alternate cleaning process for printed circuit boards.
P970004/S092
10/1/10 		InterStim® Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432		 Addition of an alternate vendor for the printed wiring boards (PWBs) and manufacturing changes for PWB components.
P970004/S093
10/14/10 		InterStim II® Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432		 Additional supplier for hybrid components and to qualify two suppliers to perform surrogate inspections.
P970020/S057
10/15/10 		Multi-Link OTW Zeta® Coronary Stent System and Multi-Link RX Zeta® Coronary Stent System Abbott Vascular, Inc.
Santa Clara, CA
95054		 Change to the methodology for sterilization dose audits.
P970027/S010
10/19/10 		AxSYM Anti-HCV Abbott Laboratories
Abbott Park IL
60064		 Modifications to the common accessory for AxSYM hepatitis products.
P980007/S012
10/20/10 		AxSYM Free PSA Abbott Laboratories
Abbott Park, IL 60064		 Modification to a common accessory for AxSYM assays.
P980016/S259
10/15/10 		Marquis, Maximo, and Intrinsic ICDs Medtronic, Inc.
Mounds View, MN
55112		 Change to the EFTE coating inspection process.
P980016/S260
10/15/10 		Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR, and Virtuoso Families of ICDs Medtronic, Inc.
Cardiac Rhythm and Disease Management
Mounds View, MN
55112		 Addition of a second supplier for the BPA component and a change in the component inspection process.
P980022/S085
10/13/10 		Paradigm Real-Time Insulin Pump Medtronic, Inc.
Northridge, CA
91325		 New bonder tooling process.
P980035/S188
10/15/10 		Adapta/Versa/ Sensia IPG, Relia IPG, and EnRhythm IPG Medtronic, Inc.
Cardiac Rhythm and Disease Management
Mounds View, MN
55112		 Addition of a second supplier for the BPA component and a change in the component inspection process.
P990020/S041
10/27/10 		AneuRx Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403		 Transfer of post sterilization inspections to an alternate site.
P000025/S048
10/1/10 		COMBI 40+ Cochlear Implant System MED-EL Corporation
Durham, NC
27713		 Addition of another supplier for the Feedthrough Assembly component.
P000037/S020
10/29/10 		Ox-X® Prosthetic Heart Valve On-X Life Technologies, Inc.
Austin, TX
78752		 Use of additional manufacturing equipment at the Anderson Lane facility.
P010012/S257
10/8/10 		Contak Renewal, Livian, Cognis Families of CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112		 Addition of a supplier for a capacitor component.
P010031/S215
10/15/10 		InSync II Marquis, InSync III Marquis, InSync Sentry, and InSync Maximo ICDs Medtronic, Inc.
Mounds View, MN
55112		 Change to the EFTE coating inspection process.
P010031/S216
10/15/10 		Concerto II, Consulta,
Maximo II, and Concerto Families of CRT-Ds		 Medtronic, Inc.
Cardiac Rhythm and Disease Management
Mounds View, MN
55112		 Addition of a second supplier for the BPA component and a change in the component inspection process.
P010047/S006
10/14/10 		NeoMend Pro-Gel™ Pleural Air Leak Sealant NeoMend, Inc.
Irvine, CA
92618		 Addition of a second source for human serum albumin.
P020047/S024
10/15/10 		Multi-Link Vision® RX Coronary Stent System and
Multi-Link Vision® OTW Coronary Stent System		 Abbott Vascular, Inc.
Santa Clara, CA
95054		 Change to the methodology for sterilization dose audits.
P020047/S025
10/27/10 		Multi-Link 8™, Multi-Link 8™ LLO, and Multi-Link 8™ SV Coronary Stent Systems Abbott Vascular
Temecula, CA
92590		 Addition of a supplier for the device component.
P030005/S071
10/1/10 		Contak Renewal TR/TR2 Pulse
Generator		 Boston Scientific Corporation
St. Paul, MN
55112		 Addition of a redundant dye and shear test, and an increase of sample size for testing surge suppressors in the manufacturing of pulse generators.
P030009/S045
10/29/10 		Integrity Coronary Stent Systems Medtronic Vascular
Santa Rosa, CA
95403		 Modifications to the Vision Assist Precision OD Welder.
P030009/S046
10/27/10 		Driver, Micro-Driver, and Integrity Coronary Stent Systems Medtronic Vascular
Santa Rosa, CA
95403		 Transfer of post sterilization inspections to an alternate site.
P030017/S108
10/8/10 		Precision Spinal Cord Stimulator System Boston Scientific Corporation
Valencia, CA
91355		 Addition of an alternate supplier for the antenna coil component.
P030017/S109
10/8/10 		Precision Spinal Cord Stimulator System Boston Scientific Corporation
Valencia, CA
91355		 Addition of an alternate supplier for the Coil Lead Frame component.
P030029/S011
10/18/10 		ADVIA Centaur Anti-HBs ReadyPack Reagents and Calibrators Siemens Healthcare Diagnostics
East Walpole, MA
02032		 Manufacturing change to eliminate a quality control test.
P030054/S171
10/19/10 		Atlas+ HF, Atlas II+ HR, Epic HF, Promote RF, Promote+, Promote Accel, and Unify ICDs/CRT-Ds St. Jude Medical
Sunnyvale, CA
94086		 Extension of primer dwell time from 24 to 72 hours.
P030054/S172
10/29/10 		Epic HF/Atlas+ HF Family of CRT-Ds St. Jude Medical, Inc.
Sylmar, CA
91392		 Modifications to the automated manufacturing tests (ATE).
P040012/S033
10/15/10 		Acculink™ Carotid Stent System Abbott Vascular, Inc.
Santa Clara, CA
95054		 Change to the methodology for sterilization dose audits.
P040021/S013
10/29/10 		St. Jude Medical Biocor™,
Biocor™ Supra, Epic™, and
Epic Supra™ Heart Valves		 St. Jude Medical
St. Paul, MN
55117		 Addition of a supplier of bovine pericardial tissue.
P050034/S003
10/29/10 		Implantable Miniature Telescope™ (IMT) VisionCare™ Ophthalmic Technologies
Saratoga, CA
95070		 Introduction of an additional Laser Welding System II.
P050049/S004
10/19/10 		AxSYM HBsAg/ Confirmatory Abbott Laboratories
Abbott Park IL
60064		 Modifications to the common accessory for AxSYM hepatitis products.
P060001/S010
10/4/10 		Protégé® GPS and Protégé® RX Carotid Stent System Ev3, Inc.
Plymouth, MN
55441		 Manual to automated manufacturing change in the finishing process.
P060003/S006
10/19/10 		AxSYM AUSAB Abbott Laboratories
Abbott Park IL
60064		 Modifications to the common accessory for AxSYM hepatitis products.
P060006/S016
10/8/10 		Express® SD Renal Monorail™ Premounted Stent System Boston Scientific
Maple Grove, MN
55311		 Addition of an automated stent inspection step.
P060009/S002
10/19/10 		AxSYM CORE-M 2.0 Abbott Laboratories
Abbott Park IL
60064		 Modifications to the common accessory for AxSYM hepatitis products.
P060012/S003
10/20/10 		AxSYM CORE 2.0 Abbott Laboratories
Abbott Park IL
60064		 Change to the manufacturing process and quality control test method for the HBcAg Solution and the change to the manufacturing process for the Qualified rHBcAg used in the AxSYM CORE 2.0 assay.
P060012/S004
10/19/10 		AxSYM CORE 2.0 Abbott Laboratories
Abbott Park IL
60064		 Modifications to the common accessory for AxSYM hepatitis products.
P060019/S014
10/29/10 		Cool Point Tubing Set St. Jude Medical
Irvine, CA
92614		 Additional sterilization chamber by the contract sterilizer.
P060025/S007
10/15/10 		ATS 3f® Aortic Bioprosthesis ATS Medical, Inc.
Lake, Forest, CA
92630		 Additional suppliers of equine tissue.
P070007/S022
10/27/10 		Talent Thoracic Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403		 Transfer of post sterilization inspections to an alternate site.
P070014/S019
10/27/10 		Bard® Lifestent® Vascular Stent Systems Bard Peripheral Vascular, Inc.
Tempe, AZ
85280		 Formulation change to a joining material.
P070015/S047
10/4/10 		XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) Abbott Vascular
Santa Clara, CA
95054		 Modification to the bioburden testing frequency.
P070015/S048
10/12/10 		XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) Abbott Vascular
Santa Clara, CA
95054		 Modification to manufacturing equipment settings in the stent finishing process.
P070022/S006
10/7/10 		Adiana® Permanent Contraception System Hologic, Inc.
Marlborough, MA
01752		 Change in the classification of a portion of a cleanroom.
P070027/S022
10/27/10 		Talent Abdominal Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403		 Transfer of post sterilization inspections to an alternate site.
P080014/S004
10/26/10 		Cervista® HPV HR Hologic, Inc.
Marlborough, MA
01752		 Changes in the fill volume of the wash buffer and an increase in sample size of the incoming components being tested.
P090003/S006
10/13/10 		Express® LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Modification of a foreign material inspection procedure.
P090003/S007
10/8/10 		Express® LD Iliac Premounted Stent System Boston Scientific
Maple Grove, MN
55311		 Addition of an automated stent inspection step.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 63

Summary of PMA Originals Under Review
Total Under Review: 93
Total Active: 36
Total On Hold: 57
Number Greater Than 180 Days: 5

Summary of PMA Supplements Under Review
Total Under Review: 644
Total Active: 436
Total On Hold: 208
Number Greater Than 180 Days: 13

Summary of All PMA Submissions Received
Originals: 1
Supplements: 66

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 63
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 143.51
FDA Time: 95.46 Days MFR Time: 48.05 Days

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