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U.S. Department of Health and Human Services

Medical Devices

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January 2011 PMA Approvals

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.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P100028
1/14/11
Formula™ Balloon- Expandable Renal Stent SystemCook Incorporated Bloomington, IN
47404
 
Approval for the Formula™ Balloon- Expandable Renal Stent System. This device is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (PTRA) of a de novo or restenotic lesion (≤ 18 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0 – 7.0 mm. Sub-optimal PTRA is defined as ≥ 50% residual stenosis, ≥ 20 mmHg systolic or ≥ 10 mmHg mean translesional pressure gradient, or flow-limiting dissection.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P830055/S117
1/10/11
Special
LCS® Total Knee SystemDePuy Orthopaedics, Inc. Warsaw, IN
46581
Approval for an additional inspection step to the manufacturing process of the Sigma PS Femoral Components and the Sigma PS Femoral Components with Lugs
P840001/S175
1/20/11
Special
Spinal Cord Stimulation SystemsMedtronic Neuromodulation Minneapolis, MN 55432Approval to add new precautions required for compliance with applicable portions of the “IEC 60601-1 Standard for Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance.”
P850007/S030
1/12/11
180-Day
Physio-Stim/Spinal-Stim and Cervical-StimOrthofix, Inc.
Lewisville, TX
75056
 
Approval for a manufacturing site located in Lewisville, Texas.
P860003/S055
1/25/11
135-Day
UVAR™ XTS Procedural KitTherakos, Inc. Raritan, NJ
08869
Approval for use of a new welder in manufacturing the centrifuge bowl.
P860004/S129
1/14/11
180-Day
SynchroMed and SynchroMed EL Implantable Infusion PumpsMedtronic Neuromodulation Minneapolis, MN 55432Approval for a manufacturing site located at Benchmark Electronics ( Thailand) Public Company Limited in Ayudhaya, Thailand.
P900056/S101
1/7/11
Real-Time
Rotablator™ Rotational Angioplasty SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for a material and vendor change for the infusion hose of the Rotablator™ RotaLink™ Plus and RotaLink Advancer and Exchangeable Catheter.
P910001/S034
1/10/11
180-Day
CVX-300 Excimer Laser SystemSpectranetics Corporation
Colorado Springs, CO
80921
Approval for a manufacturing site located at Spectranetics Corp., in Colorado Springs, Colorado.
P910007/S024
1/13/11
Special
ARCHITECT Total PSAAbbott Laboratories Abbott Park, IL 60064Approval to add a quality control test for an incoming raw material for the ARCHITECT Pre-Trigger Solution.
P920047/S040
1/26/11
180-Day
Blazer II Cardiac Ablation CatheterBoston Scientific Corporation
San Jose, CA
95134
Approval for a manufacturing site located at Boston Scientific Corp., Heredia, Costa Rica.
P930031/S028
1/7/11
135-Day
WALLSTENT® (Tips, Iliac, Venous) Endoprosthesis with Unistep TM Plus Delivery SystemBoston Scientific Corporation Maple Grove, MN 55311Approval for a modified test method and specification extractables testing of PEBAX resin material.
P940019/S023
1/7/11
135-Day
WALLSTENT® (Tips, Iliac, Venous) Endoprosthesis with Unistep TM Plus Delivery SystemBoston Scientific Corporation Maple Grove, MN 55311Approval for a modified test method and specification extractables testing of PEBAX resin material.
P950020/S040
1/7/11
135-Day
Flextome® Cutting Balloon in both Monorail or Over-the-WireBoston Scientific Corporation Maple Grove, MN 55311Approval for a modified test method and specification extractables testing of PEBAX resin material.
P950022/S69
1/24/11
180-Day
Durata and 7F Lead FamiliesSt. Jude Medical Sylmar, CA
91342
Approval for 1) design modifications to the suture sleeve of all commercially available Durata leads; 2) 7F suture sleeve accessory kit compatible with all SJM 7F leads; 3) reduction in PVP (FastPass) coating length for all dual-shock versions of commercially available Durata leads; and 4) design modifications to the IS-1 connector crimp connection for all trifurcated versions of the commercially- available Durata leads.
P950032/S061
1/7/11
Special
Apligraf®Organogenesis, Inc. Canton, MA
02021
Approval for the addition of finished product endotoxin release testing for Apligraf®.
P950034/S037
1/19/11
Real-Time
Seprafilm® Adhesion BarrierGenzyme Corporation
Cambridge, MA
02142
Approval for the addition of a “quarter sheet” configuration to the Seprafilm® Adhesion Barrier product line.
P960009/S092
1/26/11
180-Day
Activa SC Implantable NeurostimulatorsMedtronic Neuromodulation Minneapolis, MN 55432Approval for the Activa SC implantable neurostimulator models 37602 and 37603.
P960009/S106
1/20/11
Special
Activa Deep Brain Stimulation (DBS) TherapyMedtronic Neuromodulation Minneapolis, MN 55432Approval to add new precautions required for compliance with applicable portions of the “IEC 60601-1 Standard for Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance.”
P960016/S033
1/7/11
Real-Time
Livewire TC Cardiac Ablation CathetersSt. Jude Medical Minnetonka, MN 55345Approval for the following: For only the unidirectional Livewire TC model - a modification of the tip attachment design and change of distal tip heat shrink tubing material from PTFE to PTE. For both the unidirectional and bidirectional Livewire TC models - automation of the epoxy mixing and application process during assembly of the pull wire, removal of in-process pull test requirement, increase in the length tolerance of the flat wire by 0.1 inches and automation of the dispensing of braze paste.
P970003/S119
1/21/11
Real-Time
VNS Therapy SystemCyberonics, Inc. Houston, TX
77058
Approval for the Aspire HC Model 105 Generator.
P970004/S098
1/11/11
Real-Time
Medtronic InterStim® Therapy for Urinary ControlMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for minor labeling changes to the Model 8840/ 8870 Programming Guide to mitigate the effects of the observed locking of the Clinician Programmer’s infrared communication port after printing programming session reports.
P970008/S053
1/7/11
Real-Time
Urologix Targis®
System
Urologix, Inc.
Minneapolis, MN 55447
Approval for modification of the CTC Advance microwave treatment catheter to incorporate an additional set of coolant output holes.
P970021/S029
1/19/11
135-day
G ynecare Thermachoice III Uterine Balloon Therapy SystemEthicon, Inc.
Somerville, NJ
08876
Approval for a change in a component supplier.
P970037/S003
1/12/11
180-Day
 
DELFIA Xpress hAFP Test SystemWallac OY
Turku, FI
Approval to extend the AutoDELFIA hAFP kit onto the DELFIA Xpress instrument. The modified version, namely, DELFIA Xpress hAFP kit is designed to be used with the 6000 DELFIA Xpress clinical random access screening platform. The device, as modified, will be marketed under the trade name DELFIA Xpress hAFP kit and is indicated for ‘the quantitative determination of human alpha-fetoprotein (AFP) in maternal serum and amniotic fluid obtained between the 15 th and 20 th weeks of gestation. The assay is to be performed on the 6000 DELFIA Xpress clinical random access screening platform and is intended for use only in conjunction with other diagnostic tools such as ultrasound and amniography as an aid in the detection of Open Neural Tube Defects (ONTDs).
P980003/S027
1/21/11
Real-Time
Chilli® Cooled Ablation SystemBoston Scientific Corporation
San Jose, CA
95134
Approval for packaging design change for the Chilli® Tubing Kit Model 2104.
P980007/S015
1/13/11
Special
ARCHITECT Free PSAAbbott Laboratories Abbott, IL
60064
Approval to add a quality control test for an incoming raw material for the ARCHITECT Pre-Trigger Solution.
P980022/S090
1/7/11
Real-Time
Medtronic Minimed Continuous Glucose Monitoring SystemMedtronic, Inc.
Northridge, CA 91325
Approval for a modification to the design specification of the lumen tubing used in the manufacturing process of the glucose sensor to allow for less dimensional variation in the tubing supplied by the tubing vendor.
P980022/S092
1/31/11
Real-Time
Medtronic Minimed Continuous Glucose Monitoring SystemMedtronic, Inc.
Northridge, CA
91325
Approval for a software change to the CareLink® Personal Therapy Management Software for Diabetes, MMT-7333, from version 5.3A to 5.4A.
P980033/S017
1/7/11
135-Day
WALLSTENT® Endoprosthesis with Unistep TM Plus Delivery SystemBoston Scientific Corporation Maple Grove, MN 55311Approval for a modified test method and specification extractables testing of PEBAX resin material.
P990027/S016
1/26/11
135-Day
TECHNOLAS 217z Zyoptix SystemTechnolas Perfect Vision GmbH Munchen, GermanyApproval for: 1) a single part hard disk drive; 2) an additional calibration tool; 3) change the sputter process of the aperture; and 4) production of the high pressure unit and associated testing outsourced to a new supplier.
P990040/S015
1/26/11
Real-Time
TRUFILL™
n-Butyl Cyanoacrylate
(n-BCA) Liquid Embolic System
Codman & Shurtleff, Incorporated
Raynham, MA
02767
Approval for minor packaging and labeling changes related to the replacement of Ethodized Oil with LIPIODOL as a device component for use in the TRUFILL™ n-Butyl Cyanoacrylate (nBCA) Liquid Embolic System.
P990042/S008
1/14/11
180-Day
DiaSorin ETI-AB-AUK PLUS Assay on the ETI-MAX 3000™ AnalyzerDiaSorin, Inc. Stillwater, MN
55082
Approval for the ETI-AB-AUK Plus assay on the ETI-MAX 3000™ Analyzer.
P000006/S022
1/24/11
Real-Time
Titan Inflatable Penile ProsthesisColoplast Corporation
Minneapolis, MN
55411
Approval for modifications to the reservoir component (i.e., the Cloverleaf (CL) Reservoir) and associated labeling changes.
P000037/S018
1/14/11
180-Day
On-X® Ascending Aortic Prosthesis (AAP)On-X Life Technologies, Inc.
Austin, Texas
78754
Approval for a manufacturing site located at Vascutek, Ltd., Scotland, Great Britain (UK). Also approval for a valved conduit. The device, as modified, will be marketed under he trade name On-X® Ascending Aortic Prosthesis and is indicated for the replacement of a diseased, damaged, or malfunctioning native or prosthetic heart valve in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.
P000039/S037
1/4/11
180-Day
Amplatzer Septal OccluderAGA Medical Corporation
Plymouth, MN
55442
Approval of the post-approval study protocol.
P000046/S019
1/24/11
180-Day
AnikaVisc™Anika Therapeutics, Incorporated
Bedford, MA
01730
Approval for a new trade name. The device, as modified, will be marketed under the trade name AnikaVisc™.
P000054/S026
1/26/11
180-Day
INFUSE® Bone GraftMedtronic Sofamor Danek
Memphis, TN
38132
Approval for a manufacturing site located at Integra NeuroSciences PR, Inc., Añasco, Puerto Rico.
P000058/S039
1/26/11
180-Day
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek
Memphis, TN
38132
Approval for a manufacturing site located at Integra NeuroSciences PR, Inc., Añasco, Puerto Rico.
P010014/S028
1/7/11
Real-Time
Oxford Partial Knee SystemBiomet, Inc.
Warsaw, IN
46581
Approval for changes to the package insert, including the addition of MR Conditional labeling and the associated MR conditions of use.
P010030/S021
1/10/11
180-Day
LifeVest Wearable DefibrillatorZOLL Lifecor Corporation Pittsburgh, PA 15238Approval for a manufacturing site located in Pittsburgh, Pennsylvania.
P020009/S062
1/7/11
135-Day
Express 2® Coronary Stent SystemBoston Scientific Corporation Maple Grove, MN 55311Approval for a modified test method and specification extractables testing of PEBAX resin material.
P020025/S021
1/26/11
180-Day
Blazer II XP Cardiac Ablation CatheterBoston Scientific Corporation
San Jose, CA
95134
Approval for a manufacturing site located at Boston Scientific Corp., Heredia, Costa Rica.
P020036/S020
1/31/11
135-Day
SMART® and SMART Control Nitinol Stent SystemsCordis Corporation
Miami Lakes, FL 33014
Approval for a change to the temperature set point in the sub-assembly process.
P030011/S009
1/4/11
180-Day
The Syncardia Temporary Total Artificial Heart (TAH-T) SystemSyncardia Systems, Inc.
Tucson, AZ
85713
Approval of the post-approval study protocol.
P030017/S112
1/20/10
Real-Time
Precision® Spinal Cord Stimulation (SCS) SystemBoston Scientific Neuromodulation Corporation
Valencia, CA
91355
Approval for a suture sleeve configuration with an embedded set screw for use in securing the lead.
P030025/S087
1/7/11
135-Day
Taxus® Express 2® Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation Maple Grove, MN 55311Approval for a modified test method and specification extractables testing of PEBAX resin material.
P030034/S004
1/12/11
180-Day
Physio-Stim/Spinal-Stim and Cervical-StimOrthofix, Inc.
Lewisville, TX
75056
 
Approval for a manufacturing site located in Lewisville, Texas.
P040002/S029
1/20/11
Real-Time
PowerLink Stent GraftEndologix, Inc. Irvine, CA
92618
Approval for consolidation of all inner core configurations for the 17Fr IntuiTrak Accessory Delivery System.
P040014/S015
1/11/11
Real-Time
Therapy, Therapy Cool Path and Therapy Dual 8 Ablation CathetersSt. Jude Medical
Irvine, CA
92614
Approval for a design modification to the tip electrode stem outer diameter (OD) so that the gap between the tip electrode OD and tube inside diameter (ID) is reduced for consistent gap interference.
P040016/S055
1/7/11
135-Day
VeriFLEX™ (Liberté®) Bare Metal Coronary Stent SystemBoston Scientific Corporation Maple Grove, MN 55311Approval for a modified test method and specification extractables testing of PEBAX resin material.
P040034/S019
1/20/11
Special
DuraSeal® Dural Sealant SystemCovidien
Bedford, MA
01730
Approval for a modification to the instructions for use to instruct the surgeon in the best practices in applying the sealant.
P040037/S030
1/13/11
180-Day
Gore VIABAHN® EndoprosthesisW.L. Gore & Associates, Inc. Flagstaff, AZ
86001
Approval for the 5, 6, 7 and 8 mm VIABAHN 3.18/3.18H devices, in the same endoprosthesis lengths currently approved for use in the SFA.
P040042/S020
1/11/11
Real-Time
Therapy, Therapy Cool Path and Therapy Dual 8 Ablation CathetersSt. Jude Medical
Irvine, CA
92614
Approval for a design modification to the tip electrode stem outer diameter (OD) so that the gap between the tip electrode OD and tube inside diameter (ID) is reduced for consistent gap interference.
P050006/S014
1/5/11
180-Day
Gore HELEX Septal OccluderW.L. Gore & Associates, Inc. Flagstaff, AZ
86001
Approval for updated device labeling.
P050006/S016
1/5/11
180-Day
Gore HELEX Septal OccluderW.L. Gore & Associates, Inc.
Flagstaff, AZ
860001
Approval for updated device labeling.
P050007/S027
1/7/11
Real-Time
StarClose SE Vascular Closure System (VCS)Abbott Vascular Devices
Redwood City, CA
94063
Approval for minor design changes to the Vessel Locator Spring and Spring Retainer components.
P050010/S007
1/14/11
180-Day
ProDisc-L™ Total Disc ReplacementSynthes Spine
West Chester, PA
19380
Approval for a manufacturing site located at Synthes (USA) in West Chester, Pennsylvania.
P050016/S007
1/13/11
Real-Time
Cormet Hip Resurfacing SystemCorin USA
Tampa, FL
33612
Approval for modifications to the labeling for the Cormet Hip Resurfacing System which is indicated for hybrid fixation: cemented femoral head and cementless acetabular component. The Cormet Hip Resurfacing System is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions: 1) non- inflammatory degenerative arthritis such as osteoarthritis and avascular necrosis; and 2) inflammatory arthritis such as rheumatoid arthritis. The Cormet Hip Resurfacing System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.
P050019/S005
1/7/11
135-Day
Carotid WALLSTENT® Monorail® EndoprosthesisBoston Scientific Corporation Maple Grove, MN 55311Approval for a modified test method and specification extractables testing of PEBAX resin material.
P050020/S022
1/14/11
180-Day
Freestyle Navigator Continuous Glucose Monitoring SystemAbbott Diabetes Care
Alameda, CA
94502
Approval for changes to the outgoing Quality Control (QC) solution testing.
P050042/S006
1/4/11
180-Day
ARCHITECT Anti-HCVAbbott Laboratories Abbott Park, IL 60064Approval for a manufacturing site located at Abbott GmbH & Co. KG, Delkenheim, Germany.
P050042/S008
1/14/11
Special
ARCHITECT Anti-HCVAbbott Laboratories Abbott Park, IL 60064Approval to add a quality control test for an incoming raw material for the ARCHITECT Pre-Trigger Solution.
P050051/S008
1/14/11
Special
ARCHITECT AUSABAbbott Laboratories Abbott Park, IL
60064
Approval to add a quality control test for an incoming raw material for the ARCHITECT Pre-Trigger Solution.
P050053/S017
1/26/11
180-Day
INFUSE® Bone GraftMedtronic Sofamor Danek
Memphis, TN
38132
Approval for a manufacturing site located at Integra NeuroSciences PR, Inc., Añasco, Puerto Rico to perform post-alkali treatment steps for the absorbable collagen sponge (ACS).
P060006/S011
1/7/11
135-Day
Express® SD Renal Monorail® Premounted Stent SystemBoston Scientific Corporation Maple Grove, MN 55311Approval for a modified test method and specification extractables testing of PEBAX resin material.
P060007/S006
1/14/11
Special
ARCHITECT HBsAg and HBsAg ConfirmatoryAbbott Laboratories Abbott Park, IL 60064Approval to add a quality control test for an incoming raw material for the ARCHITECT Pre-Trigger Solution.
P060008/S048
1/7/11
135-Day
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation Maple Grove, MN 55311Approval for a modified test method and specification extractables testing of PEBAX resin material.
P060019/S015
1/11/11
Real-Time
Therapy, Therapy Cool Path and Therapy Dual 8 Ablation CathetersSt. Jude Medical
Irvine, CA
92614
Approval for a design modification to the tip electrode stem outer diameter (OD) so that the gap between the tip electrode OD and tube inside diameter (ID) is reduced for consistent gap interference.
P060035/S002
1/4/11
180-Day
ARCHITECT CORE-MAbbott Laboratories Abbott Park, IL 60064Approval for a manufacturing site located at Abbott GmbH & Co. KG, Delkenheim, Germany.
P060035/S004
1/14/11
Special
ARCHITECT CORE-MAbbott Laboratories
Abbott Park, IL 60064
Approval to add a quality control test for an incoming raw material for the ARCHITECT Pre-Trigger Solution.
P060037/S012
1/31/11
180-Day
NexGen Flex LPS Mobile Bearing KneeZimmer, Inc.
Warsaw, IN
46581
Approval for a manufacturing site located at Zimmer Orthopedic MFG Ltd. (AOLM), in Shannon Industrial Estate, Ireland and a sterilization site located at Isotron, Westport, Ireland.
P060039/S016
1/13/11
180-Day
Attain StarFix Left Ventricular Lead
 
Medtronic, Inc. Mound View, MN 55112Approval of the post-approval study protocol.
P070001/S004
1/14/11
180-Day
ProDisc-C™ Total Disc ReplacementSynthes Spine
West Chester, PA
19380
Approval for a manufacturing site located at Synthes (USA) in West Chester, Pennsylvania.
P070007/S024
1/4/11
180-Day
The Talent Thoracic Stent Graft SystemMedtronic Vascular Santa Rosa, CA
95403
Approval of the post-approval study protocol.
P070015/S045
1/14/11
135-Day
XIENCE V® and PROMUS™ Everolimus-Eluting Coronary Stent SystemsAbbott Vascular, Inc.
Temecula, CA
92591
Approval for certain changes to the test method for determining impurities in the PBMA excipient.
P080006/S014
1/13/11
180-Day
Attain StarFix Left Ventricular ( LV) Lead
 
Medtronic, Inc. Mounds View, MN 55112Approval of the post-approval study protocol.
P080023/S002
1/4/11
180-Day
ARCHITECT COREAbbott Laboratories Abbott Park, IL 60064Approval for a manufacturing site located at Abbott GmbH & Co. KG, Delkenheim, Germany.
P080023/S004
1/14/11
Special
ARCHITECT COREAbbott Laboratories
Abbott Park, IL 60064
Approval to add a quality control test for an incoming raw material for the ARCHITECT Pre-Trigger Solution.
P090006/S003
1/14/11
180-Day
Complete SE Vascular Stent SystemMedtronic Vascular Santa Rosa, CA
95403
Approval for an alternate sterilization site located at Isotron Ireland Ltd., Offaly, Ireland.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
D970003/S126
1/19/11
Altrua, Insignia Pulse GeneratorsBoston Scientific Corporation
St. Paul, MN
55112
Automation of inspections for the pulse generators.
P820033/S007
1/28/11
Plasmaflo
OP-05W(A)
Asahi Kasei Kuraray Medical Company, Ltd.
Tokyo, Japan
101-8101
A new polymer supplier.
P830037/S051
1/11/11
Dura Soft 3 (phemfilcon A) Soft Contact Lenses for Extended CareCIBA VISION Corporation Duluth, GA
30097
Alternate supplier for Methacrylic Acid (MAA).
P840001/S172
1/5/11
Restore, Itrel 3, Synergy Families of Implantable Neurostimulators; Various lead families and accessoriesMedtronic Neuromodulation Minneapolis, MN 55432Upgrade of software used for statistical process control and analysis of inspection data.
P840001/S173
1/7/11
Pisces-Quad Lead Kits; 1x8 Lead Kits; Specify Surgical Leads; 2x4 Hinged Lead Kit; Intrel 3; Synergy; Synergy Family; Low Impedance Extension Kit; 8-2-4 Extension; 8-4 Extension; Restore Family; PrimeAdvanced; Octopolar Extension KitMedtronic Neuromodulation Minneapolis, MN 55432Upgrade of software used for managing quality checks and reporting of incoming materials.
P840001/S174
1/12/11
Synergy Family of Implantable NeurostimulatorsMedtronic Neuromodulation Minneapolis, MN 55432Changes to the battery testing criteria.
P840001/S176
1/26/11
External NeurostimulatorsMedtronic Neuromodulation Minneapolis, MN 55432Changes to the manufacturing of a component flex circuit.
P860004/S144
1/5/11
Synchromed II Implantable Infusion Pumps; Various catheter models and accessoriesMedtronic Neuromodulation Minneapolis, MN 55432Upgrade of software used for statistical process control and analysis of inspection data.
P860004/S145
1/7/11
Synchromed II Implantable Infusion PumpsMedtronic Neuromodulation Minneapolis, MN 55432Upgrade of software used for managing quality checks and reporting of incoming materials.
P860057/S075
1/20/11
Carpentier-Edwards PERIMOUNT Pericardial BioprosthesisEdward Lifesciences, LLC
Irvine, CA
92614
Additional supplier of polypropylene monofilament thread.
P870056/S042
1/20/11
Carpentier Edwards Porcine BioprosthesisEdward Lifesciences, LLC
Irvine, CA
92614
Additional supplier of polypropylene monofilament thread.
P870077/S038
1/20/11
Carpentier-Edwards Duraflex Mitral Low Pressure BioprosthesisEdward Lifesciences, LLC
Irvine, CA
92614
Additional supplier of polypropylene monofilament thread.
P880086/S196
1/14/11
Accent Pacers and Anthem RF CRT-P DevicesSt. Jude Medical, Inc.
Sunnyvale, CA 94086
Use of alternate UV Cure Adhesive from an alternate supplier.
P920015/S072
1/7/11
Sprint Quattro LeadsMedtronic, Inc. Mounds View, MN 55112Change to the orientation of the helix to driveshaft lug component and changes to the inspections for driveshaft lug position.
P950034/S039
1/20/11
Seprafilm Adhesion BarrierGenzyme Corporation
Framingham, MA
01701
Qualification of an alternate supplier of raw material EDC.
P960009/S104
1/5/11
Activa Family of Implantable Neurostimulators; Soletra and Kinetra Implantable Neurostiumlators; Various leads and accessoriesMedtronic Neuromodulation Minneapolis, MN 55432Upgrade of software used for statistical process control and analysis of inspection data.
P960009/S105
1/7/11
Lead Kit for Deep Brain Stimulation, Activa Family of Implantable Neurostimulators, Soletra and Kinetra Implantable Neurostimulators; Quadripolar Extension Kit for Deep Brain Stimulation; 8-4 ExtensionMedtronic Neuromodulation Minneapolis, MN 55432Upgrade of software used for managing quality checks and reporting of incoming materials.
P960009/S107
1/26/11
External NeurostimulatorsMedtronic Neuromodulation Minneapolis, MN 55432Changes to the manufacturing of a component flex circuit.
P960040/S239
1/14/11
Vitality ICDsBoston Scientific Corporation
St. Paul, MN
55112
Addition of a laser cleave cut rework process for the pulse generator capacitor stack manufacturing process.
P960040/S240
1/19/11
Prizm HE,
Prizm 3,Vitality, Vitality 2, Vitality AVT, Confient and Teligen Pulse Generators
Boston Scientific Corporation
St. Paul, MN
55112
Automation of inspections for the pulse generators.
P960043/S072
1/5/11
Perclose® AT 6F and Perclose® ProGlide™ Suture-Mediated Closure SystemAbbott Vascular, Inc.
Redwood City, CA 94063
Additional manufacturing equipment at the Sheath Coating Station.
P970004/S102
1/5/11
Interstim Family of Implantable Neurostimulators; Various leads and accessoriesMedtronic Neuromodulation Minneapolis, MN 55432Upgrade of software used for statistical process control and analysis of inspection data.
P970004/S103
1/7/11
Interstim Family of Implantable Neurostimulators; Quadripolar Extension for InterStim Therapy; Pisces Z Plus Lead KitMedtronic Neuromodulation Minneapolis, MN 55432Upgrade of software used for managing quality checks and reporting of incoming materials.
P970012/S080
1/7/11
Kappa 400 DR/SR IPGsMedtronic, Inc. Mounds View, MN 55112Relocation of a sterilizer system within an existing location.
P970027/S012
1/5/11
AxSYM Anti-HCVAbbott Laboratories
Abbott Park, IL 60064
Addition of an alternative source of dextran sulfate for the manufacture of AxSYM Anti-HCV Specimen Diluent 2.
P980016/S269
1/7/11
GEM II, Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II CR/VR, Virtuoso II DR/VR, and Secura DR/VR ICDsMedtronic, Inc. Mounds View, MN 55112Relocation of a sterilizer system within an existing location.
P980016/S270
1/13/11
Secura DR/VR, Maximo II DR/VR, and Virtuoso II DR/VR ICDsMedtronic, Inc.
Mounds View, MN 55112
Upgrade of the D363 Integrated Circuit for continuous test coverage and test methodology.
P980016/S271
1/19/11
Maximo II DR /VR, Virtuoso II DR/VR, and Secura DR/VRMedtronic, Inc. Mounds View, MN 55112Modification of test software used for final acceptance of implantable devices.
P980016/S272
1/19/11
Virtuoso II/Secura/ Maximo II ICDsMedtronic, Inc. Mounds View, MN 55112Changes to the RF test requirements used during final functional device testing.
P980022/S091
1/12/11
Continuous Glucose Monitoring SystemMedtronic, Inc. Northridge, CA 91325Minor manufacturing changes to the Sof-Sensor™ Glucose Sensor MMT-7002.
P980024/S004
1/10/11
PathVysion HER-2 DNA Probe KitAbbott Molecular, Inc.
Des Plaines, IL 60018
Process change to the manufacture of the FISH DNA Bulk Probe Solution to increase the batch range up to 2000 mL.
P980035/S198
1/6/11
AT500 System IPGMedtronic, Inc. Mounds View, MN 55112Change in the control of the installation and configuration of the application software for the automated accelerometer test system.
P980035/S199
1/7/11
Kappa 600/700, 650, 800/900, Relia, Sigma, Medtronic 350, EnPulse, EnRhythm, AT500. amd Adapta/
Versa/Sensia IPGs
Medtronic, Inc. Mounds View, MN 55112Relocation of a sterilizer system within an existing location.
P980053/S013
1/20/11
Durasphere Injectable Bulking AgentCarbon Medical Technologies, Inc. St. Paul, MN
55110
Addition of a new controlled environment area.
P990001/S081
1/7/11
Dema IPGsMedtronic, Inc. Mounds View, MN 55112Relocation of a sterilizer system within an existing location.
P990013/S030
1/13/11
STAAR Surgical Collamer Intraocular LensesSTAAR Surgical Company
Monrovia, CA
91016
Parametric release of single piece Collamer intraocular lenses.
P990034/S021
1/5/11
Side Catheter Access Port Kits and Refill KitsMedtronic, Neuromodulation Minneapolis, MN 55432Upgrade of software used for statistical process control and analysis of inspection data.
P010012/S261
1/14/11
Contak and Renewal CRT-DsBoston Scientific Corporation
St. Paul, MN
55112
Addition of a laser cleave cut rework process for the pulse generator capacitor stack manufacturing process.
P010012/S262
1/19/11
Contak Renewal 3, Livian, CognisBoston Scientific Corporation
St. Paul, MN
55112
Automation of inspections for the pulse generators.
P010013/S033
1/7/11
NovaSure Impedance Controlled Endometrial Ablation SystemHologic, Inc. Marlborough, MA 01752Annealing and mold modifications in the manufacture of the front grip component.
P010015/S105
1/6/11
InSync CRT-PMedtronic, Inc. Mounds View, MN 55112Change in the control of the installation and configuration of the application software for the automated accelerometer test system.
P010015/S106
1/7/11
InSync and InSync III CRT-Ps
 
Medtronic, Inc. Mounds View, MN 55112Relocation of a sterilizer system within an existing location.
P010031/S223
1/6/11
InSync Marquis ICDMedtronic, Inc. Mounds View, MN 55112Change in the control of the installation and configuration of the application software for the automated accelerometer test system.
P010031/S224
1/7/11
InSync, InSync Marquis, Insync II Marquis, InSync II Marquis, Insync II Protect, InSync Sentry, InSync Maximo ICDs and Concerto, Concerto II, Maximo II, and Consulta CRT-DsMedtronic, Inc. Mounds View, MN 55112Relocation of a sterilizer system within an existing location.
P010031/S225
1/13/11
Concerto II ICD, Consulta CRT-D and Maximo II CRT-DMedtronic, Inc.
Mounds View, MN 55112
Upgrade of the D363 Integrated Circuit for continuous test coverage and test methodology.
P010031/S226
1/19/11
Concerto II CRT-D, Maximo II CRT-D and Consulta
CRT-D
Medtronic, Inc. Mounds View, MN 55112Modification of test software used for final acceptance of implantable devices.
P010031/S227
1/19/11
Concerto II CRT-D, Maximo II CRT-D, and Consulta
CRT-D
Medtronic, Inc. Mounds View, MN 55112Changes to the device RF test requirements used during final functional device testing.
P010041/S026
1/20/11
Carpentier Edwards S.A.V. BioprosthesisEdward Lifesciences, LLC
Irvine, CA
92614
Additional supplier of polypropylene monofilament thread.
P020009/S068
1/13/11
Express 2® Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change in the environmental quality control procedure.
P020009/S069
1/14/11
Express/Express 2® Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Software upgrade to process equipment.
P020009/S070
1/19/11
Express 2® Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change to the catheter inspection process.
P020009/S071
1/20/11
Express 2® Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change to the port welding process.
P030005/S072
1/19/11
Contak Renewal TR Pulse GeneratorBoston Scientific Corporation
St. Paul, MN
55112
Automation of inspections for the pulse generators.
P030009/S052
1/6/11
Endeavor Zotarolimus-Eluting Coronary Stent SystemsMedtronic Ireland
Galway, EI
Removal of specified Audit OC inspection steps.
P030009/S053
1/19/11
Driver and Micro-Driver Coronary Stent SystemMedtronic Ireland
Galway, EI
Removal of redundant packaging inspections.
P030017/S113
1/12/11
Precision® Spinal Cord Stimulator (SCS) SystemBoston Scientific Valencia, CA 91355Addition of an alternate supplier for a component used in the assembly of Spinal Cord Stimulator chargers.
P030017/S114
1/20/11
Precision® Spinal Cord Stimulator (SCS) SystemBoston Scientific Valencia, CA 91355Addition of an alternate qualified supplier.
P030017/S115
1/20/11
Precision® Spinal Cord Stimulator (SCS) SystemBoston Scientific
Valencia, CA
91355
Addition of an alternate supplier for the electrodes and contacts used in the assembly of SCS leads.
P030025/S092
1/19/11
Taxus Express Atom StentBoston Scientific Corporation
Maple Grove, MN 55311
Change to your catheter inspection process.
P030035/S076
1/14/11
Accent Pacers and Anthem RF CRT-P DevicesSt. Jude Medical, Inc.
Sunnyvale, CA 94086
Use of alternate UV Cure Adhesive from an alternate supplier.
P030054/S179
1/7/11
Merlin 3650 ProgrammerSt. Jude Medical, Inc.
Sunnyvale, CA 94086
Alternate supplier for the Printed Circuit Board (PCB) used in the Merlin 3650 Programmer.
P040016/S065
1/131/11
Liberte® Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change in the environmental quality control procedure.
P040016/S066
1/14/11
VeriFLEX™ (Liberté®) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Software upgrade to process equipment.
P040016/S067
1/19/11
VeriFLEX™ (Liberté®) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change to the catheter inspection process.
P040016/S068VeriFLEX™ (Liberté®) Monorail Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change to the port welding process.
P050023/S043
1/20/11
Lumax ICDs/CRTsBiotronik, Inc. Lake Oswego, OR
97035
Removal of the 72 hour storage condition during the header attachment process.
P060006/S018
1/13/11
Express SD Renal Monorail Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change in the environmental quality control procedure.
P060008/S062
1/13/11
Taxus® Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change in the environmental quality control procedure.
P060008/S063
1/14/11
Taxus® Liberté® Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Software upgrade to process equipment.
P060008/S064
1/19/11
Taxus Liberté® Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change to the catheter inspection process.
P060008/S065
1/20/11
Taxus Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change to the port welding process.
P060033/S062
1/6/11
Driver Coronary Stent SystemsMedtronic Vascular, Inc.
Santa, Rosa, CA
Removal of specified Audit OC inspection steps.
P060038/S008
1/20/11
Mitroflow Aortic Pericardial Heart ValveSorin Group USA, Inc.
Arvada, CO
80004
Expansion of the Tissue Application Controlled Environment.
P070007/S025
1/5/11
Talent Thoracic Stent Graft with Xcelerant Delivery SystemMedtronic Vascular
Santa Rosa, CA 95403
Addition of an alternate stent crimping machine.
P070027/S026
1/5/11
Talent Abdominal Stent Graft with Xcelerant Delivery SystemMedtronic Vascular
Santa Rosa, CA 95403
Addition of an alternate stent crimping machine.
P080006/S019
1/20/11
Attain Ability Left Ventricular LeadMedtronic, Inc. Mounds View, MN 55112Move to a 50 RPM paddle speed for the tip and ring elution method.
P080014/S006
1/20/11
Cervista® HPV HRHologic, Inc.
Marlborough, MA
01752
Addition of an alternative vendor for Cervista® HPV Oligos Mix 1, Mix 2, Mix 3 used in the Cervista® HPV HR test.
P090003/S008
1/13/11
Express LD Iliac Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change in the environmental quality control procedure.
P090006/S004
1/19/11
Complete® SE Vascular Stent SystemMedtronic Ireland
Galway, EI
Removal of redundant packaging inspections.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 78

Summary of PMA Originals Under Review
Total Under Review: 95
Total Active: 44
Total On Hold: 51
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 624
Total Active: 411
Total On Hold: 213
Number Greater Than 180 Days: 12

Summary of All PMA Submissions Received
Originals: 3
Supplements: 74

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 78
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 167.0
FDA Time: 105.7 Days MFR Time: 61.3 Days