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PMA Final Decisions for October 2010

Posted Dec 27 2010 12:00am

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

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE 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.
APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N12159/S026
10/27/10
Real-Time
Surgical Absorbable HemostatEthicon, Inc.
Somerville, NJ
08876
Approval for the addition of a non-woven version of Surgicel.
N18286/S020
10/19/10
Special
Gelfoam Absorbable Gelatin SpongePfizer, 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 CathetersMedtronic 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 SystemEBI, 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 SystemsMedtronic 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 SystemsMedtronic 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 PacemakersSt. 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 PacemakersSt. 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 MonitorMedtronic, 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 ICDsSt. 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 CablesBiosense 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 GeneratorsBoston 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 PacemakersSt. 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 IPGMedtronic, 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™ KitDako 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 SystemMedtronic, 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 SystemMedtronic, 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 PumpMedtronic, 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 FamilyMedtronic, 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 LaserAngioDynamics
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 CablesBiosense 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 SystemsMedtronic 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 SystemsMedtronic 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 CablesBiosense 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) SystemAllergan, 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 GelOceana 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 GeneratorsBoston 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 CablesBiosense 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, GraftWL 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 SystemsApplied 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 SystemsMedtronic 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 SystemSiemens 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 HeartSynCardia Systems, Inc.
Tucson, AZ
85713
Approval of the post-approval study protocol.
P030031/S028
10/1/10
180-Day
Celsius ThermoCool Catheter, NaviStar ThermoCool CatheterBiosense 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-PsSt. 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-DsSt. 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™ KitDako 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) SystemSmith & Nephew Orthopaedics
Memphis, TN
38116
Approval for revisions to the physician and patient labeling.
P040036/S021
10/1/10
180-Day
NaviStar ThermoCool CatheterBiosense 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 OccluderAGA Medical, Inc.
Plymouth, MN
55442
Approval of the post-approval study protocol.
P040044/S033
10/22/10
Real-Time
Mynx® Cadence™ Vascular Closure DeviceAccessClosure, 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 TelescopeVisionCare Ophthalmic Technologies, Inc.
Saratoga, CA
95070
Approval of the post-approval study protocol.
P050034/S002
10/13/10
180-Day
Implantable Miniature TelescopeVisionCare 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 SystemBoston 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 SystemsMedtronic 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 SystemsZimmer, 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 LVASThoratec 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 LVASThoratec 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 SystemMedtronic 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 SystemsBard 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 SystemsBard 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 SystemAbbott 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 KitHologic, 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 SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for an alternate stent finishing process using an automated system in place of the current manual system.
APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P790017/S110
10/27/10
Gruntzig Dilaca Balloon Dilatation CathetersMedtronic Vascular
Santa Rosa, CA
95403
Transfer of post sterilization inspections to an alternate site.
P810046/S240
10/15/10
Voyager® NC Coronary Dilatation CatheterAbbott Vascular, Inc.
Santa Clara, CA
95054
Change to the methodology for sterilization dose audits.
P820060/S025
10/20/10
AxSYM AFPAbbott 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 ElectrodeMedtronic, Inc.
Mounds View, MN
55112
Addition of an alternate supplier of conductor coils.
P840001/S164
10/1/10
Restore® Family of Implantable NeurostimulatorsMedtronic 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 NeurostimulatorsMedtronic 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 ElectrodeMedtronic, Inc.
Mounds View, MN
55112
Addition of an alternate supplier of conductor coils.
P860004/S139
10/1/10
SynchroMed® Drug PumpsMedtronic 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 BioprosthesisEdwards Lifesciences
Irvine, CA
92614
Expansion of Clean Room #2 at the Changi, Singapore Manufacturing facility.
P890003/S200
10/8/10
CareLink® ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Change to the method of data entry for creating product labels.
P890003/S203
10/29/10
CapSure Implantable Pulse GeneratorMedtronic, Inc.
Mounds View, MN
55112
Addition of an alternate supplier of conductor coils.
P910001/S037
10/15/10
Spectranetics ELCA® Excimer Laser Coronary Atherectomy CathetersSpectranetics Corporation
Colorado Springs, CO
80921
Change to the label printing process.
P910007/S020
10/20/10
AxSYM Total PSAAbbott 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 ICDsSt. Jude Medical, Inc.
Sylmar, CA
91392
Modifications to the automated manufacturing tests (ATE).
P920015/S067
10/29/10
Sprint Quattro Steroid-Eluting Pacing LeadMedtronic, Inc.
Mounds View, MN
55112
Addition of an alternate supplier of conductor coils.
P930039/S045
10/29/10
CapSure Drug-Eluting Permanent Defibrillator ElectrodeMedtronic, Inc.
Mounds View, MN
55112
Addition of an alternate supplier of conductor coils.
P950034/S034
10/7/10
Seprafilm® Adhesion BarrierGenzyme Corp.
Framingham, MA
01701
New cleaning schedule for equipment used in manufacturing of the device.
P950034/S035
10/26/10
Seprafilm® Adhesion BarrierGenzyme Corp.
Framingham, MA
01701
Change in manufacturing sites.
P960006/S027
10/20/10
Flextend and Flextend 2 Extendable/ Retractable Endocardial Pacing LeadsBoston Scientific Corporation
St. Paul, MN
55112
Change in classification of the product families for elution characterization sampling.
P960009/S096
10/1/10
Activa® Implantable NeurostimulatorsMedtronic 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 NeurostimulatorsMedtronic 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 ICDsBoston Scientific Corporation
St. Paul, MN
55112
Addition of a supplier for a capacitor component.
P970003/S114
10/13/10
VNS Therapy SystemCyberonics, Inc
Houston, TX
77058
An alternate cleaning process for printed circuit boards.
P970004/S092
10/1/10
InterStim® Family of Implantable NeurostimulatorsMedtronic 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 NeurostimulatorsMedtronic 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 SystemAbbott Vascular, Inc.
Santa Clara, CA
95054
Change to the methodology for sterilization dose audits.
P970027/S010
10/19/10
AxSYM Anti-HCVAbbott Laboratories
Abbott Park IL
60064
Modifications to the common accessory for AxSYM hepatitis products.
P980007/S012
10/20/10
AxSYM Free PSAAbbott Laboratories
Abbott Park, IL 60064
Modification to a common accessory for AxSYM assays.
P980016/S259
10/15/10
Marquis, Maximo, and Intrinsic ICDsMedtronic, 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 ICDsMedtronic, 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 PumpMedtronic, Inc.
Northridge, CA
91325
New bonder tooling process.
P980035/S188
10/15/10
Adapta/Versa/ Sensia IPG, Relia IPG, and EnRhythm IPGMedtronic, 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 SystemMedtronic Vascular
Santa Rosa, CA
95403
Transfer of post sterilization inspections to an alternate site.
P000025/S048
10/1/10
COMBI 40+ Cochlear Implant SystemMED-EL Corporation
Durham, NC
27713
Addition of another supplier for the Feedthrough Assembly component.
P000037/S020
10/29/10
Ox-X® Prosthetic Heart ValveOn-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-DsBoston 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 ICDsMedtronic, 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 SealantNeoMend, 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 SystemsAbbott 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 SystemsMedtronic 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 SystemsMedtronic Vascular
Santa Rosa, CA
95403
Transfer of post sterilization inspections to an alternate site.
P030017/S108
10/8/10
Precision Spinal Cord Stimulator SystemBoston Scientific Corporation
Valencia, CA
91355
Addition of an alternate supplier for the antenna coil component.
P030017/S109
10/8/10
Precision Spinal Cord Stimulator SystemBoston 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 CalibratorsSiemens 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-DsSt. 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-DsSt. Jude Medical, Inc.
Sylmar, CA
91392
Modifications to the automated manufacturing tests (ATE).
P040012/S033
10/15/10
Acculink™ Carotid Stent SystemAbbott 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/ ConfirmatoryAbbott 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 SystemEv3, Inc.
Plymouth, MN
55441
Manual to automated manufacturing change in the finishing process.
P060003/S006
10/19/10
AxSYM AUSABAbbott 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 SystemBoston Scientific
Maple Grove, MN
55311
Addition of an automated stent inspection step.
P060009/S002
10/19/10
AxSYM CORE-M 2.0Abbott Laboratories
Abbott Park IL
60064
Modifications to the common accessory for AxSYM hepatitis products.
P060012/S003
10/20/10
AxSYM CORE 2.0Abbott 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 2.0Abbott Laboratories
Abbott Park IL
60064
Modifications to the common accessory for AxSYM hepatitis products.
P060019/S014
10/29/10
Cool Point Tubing SetSt. Jude Medical
Irvine, CA
92614
Additional sterilization chamber by the contract sterilizer.
P060025/S007
10/15/10
ATS 3f® Aortic BioprosthesisATS Medical, Inc.
Lake, Forest, CA
92630
Additional suppliers of equine tissue.
P070007/S022
10/27/10
Talent Thoracic Stent Graft SystemMedtronic Vascular
Santa Rosa, CA
95403
Transfer of post sterilization inspections to an alternate site.
P070014/S019
10/27/10
Bard® Lifestent® Vascular Stent SystemsBard 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 SystemHologic, Inc.
Marlborough, MA
01752
Change in the classification of a portion of a cleanroom.
P070027/S022
10/27/10
Talent Abdominal Stent Graft SystemMedtronic Vascular
Santa Rosa, CA
95403
Transfer of post sterilization inspections to an alternate site.
P080014/S004
10/26/10
Cervista® HPV HRHologic, 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 SystemBoston Scientific Corporation
Maple Grove, MN
55311
Modification of a foreign material inspection procedure.
P090003/S007
10/8/10
Express® LD Iliac Premounted Stent SystemBoston 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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