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PMA Final Decisions for January 2012

Tue, 03/13/2012 - 1:31pm
U.S. Food & Drug Administration

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 APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P100028

1/14/11

Formula™ Balloon- Expandable Renal Stent System Cook 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.
APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P830055/S117

1/10/11

Special

LCS® Total Knee System DePuy 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 Systems Medtronic Neuromodulation Minneapolis, MN 55432 Approval 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-Stim Orthofix, Inc.

Lewisville, TX

75056

Approval for a manufacturing site located in Lewisville, Texas.
P860003/S055

1/25/11

135-Day

UVAR™ XTS Procedural Kit Therakos, 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 Pumps Medtronic Neuromodulation Minneapolis, MN 55432 Approval 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 System Boston 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 System Spectranetics 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 PSA Abbott Laboratories Abbott Park, IL 60064 Approval 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 Catheter Boston 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 System Boston Scientific Corporation Maple Grove, MN 55311 Approval 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 System Boston Scientific Corporation Maple Grove, MN 55311 Approval 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-Wire Boston Scientific Corporation Maple Grove, MN 55311 Approval for a modified test method and specification extractables testing of PEBAX resin material.
P950022/S69

1/24/11

180-Day

Durata and 7F Lead Families St. 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 Barrier Genzyme 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 Neurostimulators Medtronic Neuromodulation Minneapolis, MN 55432 Approval for the Activa SC implantable neurostimulator models 37602 and 37603.
P960009/S106

1/20/11

Special

Activa Deep Brain Stimulation (DBS) Therapy Medtronic Neuromodulation Minneapolis, MN 55432 Approval 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 Catheters St. Jude Medical Minnetonka, MN 55345 Approval 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 System Cyberonics, Inc. Houston, TX

77058

Approval for the Aspire HC Model 105 Generator.
P970004/S098

1/11/11

Real-Time

Medtronic InterStim® Therapy for Urinary Control Medtronic 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 System Ethicon, Inc.

Somerville, NJ

08876

Approval for a change in a component supplier.
P970037/S003

1/12/11

180-Day

 

DELFIA Xpress hAFP Test System Wallac 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 System Boston 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 PSA Abbott 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 System Medtronic, 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 System Medtronic, 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 System Boston Scientific Corporation Maple Grove, MN 55311 Approval for a modified test method and specification extractables testing of PEBAX resin material.
P990027/S016

1/26/11

135-Day

TECHNOLAS 217z Zyoptix System Technolas Perfect Vision GmbH Munchen, Germany Approval 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™ Analyzer DiaSorin, 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 Prosthesis Coloplast 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 Occluder AGA 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 Graft Medtronic 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 Device Medtronic 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 System Biomet, 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 Defibrillator ZOLL Lifecor Corporation Pittsburgh, PA 15238 Approval for a manufacturing site located in Pittsburgh, Pennsylvania.
P020009/S062

1/7/11

135-Day

Express 2® Coronary Stent System Boston Scientific Corporation Maple Grove, MN 55311 Approval 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 Catheter Boston 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 Systems Cordis 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) System Syncardia Systems, Inc.

Tucson, AZ

85713

Approval of the post-approval study protocol.
P030017/S112

1/20/10

Real-Time

Precision® Spinal Cord Stimulation (SCS) System Boston 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 System Boston Scientific Corporation Maple Grove, MN 55311 Approval 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-Stim Orthofix, Inc.

Lewisville, TX

75056

Approval for a manufacturing site located in Lewisville, Texas.
P040002/S029

1/20/11

Real-Time

PowerLink Stent Graft Endologix, 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 Catheters St. 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 System Boston Scientific Corporation Maple Grove, MN 55311 Approval for a modified test method and specification extractables testing of PEBAX resin material.
P040034/S019

1/20/11

Special

DuraSeal® Dural Sealant System Covidien

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® Endoprosthesis W.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 Catheters St. 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 Occluder W.L. Gore & Associates, Inc. Flagstaff, AZ

86001

Approval for updated device labeling.
P050006/S016

1/5/11

180-Day

Gore HELEX Septal Occluder W.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 Replacement Synthes 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 System Corin 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® Endoprosthesis Boston Scientific Corporation Maple Grove, MN 55311 Approval 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 System Abbott 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-HCV Abbott Laboratories Abbott Park, IL 60064 Approval for a manufacturing site located at Abbott GmbH & Co. KG, Delkenheim, Germany.
P050042/S008

1/14/11

Special

ARCHITECT Anti-HCV Abbott Laboratories Abbott Park, IL 60064 Approval to add a quality control test for an incoming raw material for the ARCHITECT Pre-Trigger Solution.
P050051/S008

1/14/11

Special

ARCHITECT AUSAB Abbott 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 Graft Medtronic 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 System Boston Scientific Corporation Maple Grove, MN 55311 Approval for a modified test method and specification extractables testing of PEBAX resin material.
P060007/S006

1/14/11

Special

ARCHITECT HBsAg and HBsAg Confirmatory Abbott Laboratories Abbott Park, IL 60064 Approval 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 System Boston Scientific Corporation Maple Grove, MN 55311 Approval 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 Catheters St. 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-M Abbott Laboratories Abbott Park, IL 60064 Approval for a manufacturing site located at Abbott GmbH & Co. KG, Delkenheim, Germany.
P060035/S004

1/14/11

Special

ARCHITECT CORE-M Abbott 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 Knee Zimmer, 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 55112 Approval of the post-approval study protocol.
P070001/S004

1/14/11

180-Day

ProDisc-C™ Total Disc Replacement Synthes 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 System Medtronic 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 Systems Abbott 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 55112 Approval of the post-approval study protocol.
P080023/S002

1/4/11

180-Day

ARCHITECT CORE Abbott Laboratories Abbott Park, IL 60064 Approval for a manufacturing site located at Abbott GmbH & Co. KG, Delkenheim, Germany.
P080023/S004

1/14/11

Special

ARCHITECT CORE Abbott 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 System Medtronic 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 APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
D970003/S126

1/19/11

Altrua, Insignia Pulse Generators Boston 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 Care CIBA 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 accessories Medtronic Neuromodulation Minneapolis, MN 55432 Upgrade 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 Kit Medtronic Neuromodulation Minneapolis, MN 55432 Upgrade of software used for managing quality checks and reporting of incoming materials.
P840001/S174

1/12/11

Synergy Family of Implantable Neurostimulators Medtronic Neuromodulation Minneapolis, MN 55432 Changes to the battery testing criteria.
P840001/S176

1/26/11

External Neurostimulators Medtronic Neuromodulation Minneapolis, MN 55432 Changes to the manufacturing of a component flex circuit.
P860004/S144

1/5/11

Synchromed II Implantable Infusion Pumps; Various catheter models and accessories Medtronic Neuromodulation Minneapolis, MN 55432 Upgrade of software used for statistical process control and analysis of inspection data.
P860004/S145

1/7/11

Synchromed II Implantable Infusion Pumps Medtronic Neuromodulation Minneapolis, MN 55432 Upgrade of software used for managing quality checks and reporting of incoming materials.
P860057/S075

1/20/11

Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis Edward Lifesciences, LLC

Irvine, CA

92614

Additional supplier of polypropylene monofilament thread.
P870056/S042

1/20/11

Carpentier Edwards Porcine Bioprosthesis Edward Lifesciences, LLC

Irvine, CA

92614

Additional supplier of polypropylene monofilament thread.
P870077/S038

1/20/11

Carpentier-Edwards Duraflex Mitral Low Pressure Bioprosthesis Edward Lifesciences, LLC

Irvine, CA

92614

Additional supplier of polypropylene monofilament thread.
P880086/S196

1/14/11

Accent Pacers and Anthem RF CRT-P Devices St. Jude Medical, Inc.

Sunnyvale, CA 94086

Use of alternate UV Cure Adhesive from an alternate supplier.
P920015/S072

1/7/11

Sprint Quattro Leads Medtronic, Inc. Mounds View, MN 55112 Change 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 Barrier Genzyme 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 accessories Medtronic Neuromodulation Minneapolis, MN 55432 Upgrade 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 Extension Medtronic Neuromodulation Minneapolis, MN 55432 Upgrade of software used for managing quality checks and reporting of incoming materials.
P960009/S107

1/26/11

External Neurostimulators Medtronic Neuromodulation Minneapolis, MN 55432 Changes to the manufacturing of a component flex circuit.
P960040/S239

1/14/11

Vitality ICDs Boston 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 System Abbott 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 accessories Medtronic Neuromodulation Minneapolis, MN 55432 Upgrade 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 Kit Medtronic Neuromodulation Minneapolis, MN 55432 Upgrade of software used for managing quality checks and reporting of incoming materials.
P970012/S080

1/7/11

Kappa 400 DR/SR IPGs Medtronic, Inc. Mounds View, MN 55112 Relocation of a sterilizer system within an existing location.
P970027/S012

1/5/11

AxSYM Anti-HCV Abbott 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 ICDs Medtronic, Inc. Mounds View, MN 55112 Relocation 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 ICDs Medtronic, 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/VR Medtronic, Inc. Mounds View, MN 55112 Modification of test software used for final acceptance of implantable devices.
P980016/S272

1/19/11

Virtuoso II/Secura/ Maximo II ICDs Medtronic, Inc. Mounds View, MN 55112 Changes to the RF test requirements used during final functional device testing.
P980022/S091

1/12/11

Continuous Glucose Monitoring System Medtronic, Inc. Northridge, CA 91325 Minor manufacturing changes to the Sof-Sensor™ Glucose Sensor MMT-7002.
P980024/S004

1/10/11

PathVysion HER-2 DNA Probe Kit Abbott 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 IPG Medtronic, Inc. Mounds View, MN 55112 Change 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 55112 Relocation of a sterilizer system within an existing location.
P980053/S013

1/20/11

Durasphere Injectable Bulking Agent Carbon Medical Technologies, Inc. St. Paul, MN

55110

Addition of a new controlled environment area.
P990001/S081

1/7/11

Dema IPGs Medtronic, Inc. Mounds View, MN 55112 Relocation of a sterilizer system within an existing location.
P990013/S030

1/13/11

STAAR Surgical Collamer Intraocular Lenses STAAR 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 Kits Medtronic, Neuromodulation Minneapolis, MN 55432 Upgrade of software used for statistical process control and analysis of inspection data.
P010012/S261

1/14/11

Contak and Renewal CRT-Ds Boston 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, Cognis Boston Scientific Corporation

St. Paul, MN

55112

Automation of inspections for the pulse generators.
P010013/S033

1/7/11

NovaSure Impedance Controlled Endometrial Ablation System Hologic, Inc. Marlborough, MA 01752 Annealing and mold modifications in the manufacture of the front grip component.
P010015/S105

1/6/11

InSync CRT-P Medtronic, Inc. Mounds View, MN 55112 Change 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 55112 Relocation of a sterilizer system within an existing location.
P010031/S223

1/6/11

InSync Marquis ICD Medtronic, Inc. Mounds View, MN 55112 Change 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-Ds Medtronic, Inc. Mounds View, MN 55112 Relocation of a sterilizer system within an existing location.
P010031/S225

1/13/11

Concerto II ICD, Consulta CRT-D and Maximo II CRT-D Medtronic, 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 55112 Modification 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 55112 Changes to the device RF test requirements used during final functional device testing.
P010041/S026

1/20/11

Carpentier Edwards S.A.V. Bioprosthesis Edward Lifesciences, LLC

Irvine, CA

92614

Additional supplier of polypropylene monofilament thread.
P020009/S068

1/13/11

Express 2® Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Change in the environmental quality control procedure.
P020009/S069

1/14/11

Express/Express 2® Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Software upgrade to process equipment.
P020009/S070

1/19/11

Express 2® Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Change to the catheter inspection process.
P020009/S071

1/20/11

Express 2® Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Change to the port welding process.
P030005/S072

1/19/11

Contak Renewal TR Pulse Generator Boston Scientific Corporation

St. Paul, MN

55112

Automation of inspections for the pulse generators.
P030009/S052

1/6/11

Endeavor Zotarolimus-Eluting Coronary Stent Systems Medtronic Ireland

Galway, EI

Removal of specified Audit OC inspection steps.
P030009/S053

1/19/11

Driver and Micro-Driver Coronary Stent System Medtronic Ireland

Galway, EI

Removal of redundant packaging inspections.
P030017/S113

1/12/11

Precision® Spinal Cord Stimulator (SCS) System Boston Scientific Valencia, CA 91355 Addition 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) System Boston Scientific Valencia, CA 91355 Addition of an alternate qualified supplier.
P030017/S115

1/20/11

Precision® Spinal Cord Stimulator (SCS) System Boston 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 Stent Boston Scientific Corporation

Maple Grove, MN 55311

Change to your catheter inspection process.
P030035/S076

1/14/11

Accent Pacers and Anthem RF CRT-P Devices St. Jude Medical, Inc.

Sunnyvale, CA 94086

Use of alternate UV Cure Adhesive from an alternate supplier.
P030054/S179

1/7/11

Merlin 3650 Programmer St. 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 System Boston Scientific Corporation

Maple Grove, MN 55311

Change in the environmental quality control procedure.
P040016/S066

1/14/11

VeriFLEX™ (Liberté®) Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Software upgrade to process equipment.
P040016/S067

1/19/11

VeriFLEX™ (Liberté®) Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Change to the catheter inspection process.
P040016/S068 VeriFLEX™ (Liberté®) Monorail Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Change to the port welding process.
P050023/S043

1/20/11

Lumax ICDs/CRTs Biotronik, 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 System Boston Scientific Corporation

Maple Grove, MN 55311

Change in the environmental quality control procedure.
P060008/S062

1/13/11

Taxus® Liberté Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Change in the environmental quality control procedure.
P060008/S063

1/14/11

Taxus® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Software upgrade to process equipment.
P060008/S064

1/19/11

Taxus Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Change to the catheter inspection process.
P060008/S065

1/20/11

Taxus Liberté Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Change to the port welding process.
P060033/S062

1/6/11

Driver Coronary Stent Systems Medtronic Vascular, Inc.

Santa, Rosa, CA

Removal of specified Audit OC inspection steps.
P060038/S008

1/20/11

Mitroflow Aortic Pericardial Heart Valve Sorin 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 System Medtronic Vascular

Santa Rosa, CA 95403

Addition of an alternate stent crimping machine.
P070027/S026

1/5/11

Talent Abdominal Stent Graft with Xcelerant Delivery System Medtronic Vascular

Santa Rosa, CA 95403

Addition of an alternate stent crimping machine.
P080006/S019

1/20/11

Attain Ability Left Ventricular Lead Medtronic, Inc. Mounds View, MN 55112 Move to a 50 RPM paddle speed for the tip and ring elution method.
P080014/S006

1/20/11

Cervista® HPV HR Hologic, 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 System Boston Scientific Corporation

Maple Grove, MN 55311

Change in the environmental quality control procedure.
P090006/S004

1/19/11

Complete® SE Vascular Stent System Medtronic 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

SOURCE

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