The Food & Drug Administration released a list of pre-market approvals granted in January:
PMA Original Approvals
| 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. |
PMA Supplemental Approvals
| 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; 1×8 Lead Kits; Specify Surgical Leads; 2×4 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
