Medical Devices
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March 2010 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 APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P090003 3/5/10 | Express® LD Iliac Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for the Express® LD Iliac Premounted Stent System. The device is indicated for the treatment of atherosclerotic lesions found in iliac arteries up to 100 mm in length, with a reference diameter of 6 mm to 10 mm. |
| P090006 3/17/10 | Complete® SE Vascular Stent System | Medtronic Vascular Santa Rose, CA 95403 | Approval for the Complete® SE Vascular Stent System (20-100mm lengths). The device is indicated for improving luminal diameter in patients with iliac stenosis in previously unstented lesions with vessel reference diameters between 4.5mm and 9.5mm and lesion lengths up to 90mm. |
| P090018 3/17/10 | Esteem® | Envoy Medical Corporation St. Paul, MN 55110 | Approval for the Esteem®. The Esteem is intended to alleviate hearing loss in patients by replicating the ossicular chain and providing additional gain. The Esteem is indicated for patients with hearing loss that meet the following criteria: 1) 18 years of age or older; 2) Stable bilateral sensorineural hearing loss; 3) Moderate to severe sensorineural hearing loss defined by Pure Tone Average (PTA); 4) Unaided speech discrimination test score greater than or equal to 40%; 5) Normally functioning Eustachian tube; 6) Normal middle ear anatomy; 7) Normal tympanic membrane; 8) Adequate space for Esteem implant determined via a high resolution CT scan; and 9) Minimum 30 days of experience with appropriately fit hearing aids. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790007/S024 3/15/10 135-Day | Hancock® I Low Porosity and Modified Orifice Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 | Approval for a change in tissue suppliers. |
| P820033/S005 3/16/10 180-Day | Plasmaflo™ OP-05W(A) | Quintiles Consulting Rockville, MD 20852 | Approval for the Plasmaflo™ OP-05W(A). The device, is intended as a replacement for the Plasmaflo™ AP-05H and the Plasmaflo™ AP-05H(L). The device will be marketed under the trade name Plasmaflo™ OP-05W(A) and is indicated for use in therapeutic procedures requiring separation of plasma from whole blood. |
| P830061/S048 3/16/10 Real-Time | CapSure SP Leads; CapSure Leads; and CapSure Sense Leads | Medtronic, Inc. Minneapolis, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P840001/S143 3/4/10 Real-Time | Spinal Cord Stimulation Therapy | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for the reformulation of the hotmelt adhesive used for the Medtronic Neuromodulation sterile barrier blister packages. |
| P850089/S063 3/16/10 Real-Time | CapSure Z Leads | Medtronic, Inc. Minneapolis, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P860004/S117 3/4/10 Real-Time | Medtronic SynchroMed® Pump and Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for the reformulation of the hotmelt adhesive used for Medtronic Neuromodulation sterile barrier blister packages. |
| P860004/S118 3/5/10 Real-Time | SynchroMed II Drug Pump | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for updating the “during discharge” battery specification for the Medtronic SynchroMed II Drug Pump Model 8637. |
| P860057/S063 3/25/10 180-Day | Carpentier-Edwards® PERIMOUNT® Pericardial Bioprostheses Heart Valves | Edwards LifeSciences, LLC Irvine, CA 92614 | Approval for a manufacturing site located at Edwards Lifesciences ( Singapore), for sterilization and final packaging processes. |
| P860057/S065 3/5/10 180-Day | PERIMOUNT Magna Mitral Pericardial Bioprosthesis | Edwards LifeSciences, LLC Irvine, CA 92614 | Approval of the post-approval study protocol. |
| P870072/S043 3/30/10 Real-Time | TLC-II PLUS Portable VAD Driver | Thoratec Corporation Pleasanton, CA 94588 | Approval for a firmware modification to the occlusion alarm algorithm in the TLC-II PLUS Driver. |
| P880006/S064 3/16/10 Real-Time | All Families of Pulse Generators, ICDs and CRTs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for version 8.1.1 Model 3330 Software for the Model 3650 Merlin Patient Care System. |
| P880086/S178 3/16/10 Real-Time | All Families of Pulse Generators, ICDs and CRTs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for version 8.1.1 Model 3330 Software for the Model 3650 Merlin Patient Care System. |
| P890003/S183 3/16/10 Real-Time | Wrench Kit | Medtronic, Inc. Minneapolis, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P890064/S021 3/31/10 180-Day | Hybrid Capture 2 High-Risk HPV DNA Test and Hybrid Capture 2 HPV DNA Test | Qiagen Gaithersburg, Inc. Gaithersburg, MN 20878 | Approval for a Trade Name change for the Hybrid Capture 2 (HC2) High-Risk HPV DNA Test and Hybrid Capture 2 (HC2) HPV DNA Test. The devices, as modified, will be marketed under the trade name digene® Hybrid Capture 2 (HC2) High-Risk HPV DNA Test and digene ® Hybrid Capture 2 (HC2) HPV DNA Test and are indicated for the qualitative detection of specified types of human papillomavirus (HPV) DNA in cervical specimens. |
| P900061/S085 3/16/10 Real-Time | Lead End Pin Cap; Active Can Emulator; Sizing Sleeve; and Upsizing Sleeve | Medtronic, Inc. Minneapolis, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P910023/S219 3/16/10 Real-Time | All Families of Pulse Generators, ICDs and CRTs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for version 8.1.1 Model 3330 Software for the Model 3650 Merlin Patient Care System. |
| P910023/S223 3/3/10 Real-Time | Cadence ICD System | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for Merlin@home Model EX2000 Version 4.5 software. |
| P910023/S224 3/3/10 Real-Time | Cadence ICD System | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for enhancements to the software (version 4.5) used in the Merlin.net system. |
| P920015/S057 3/16/10 Real-Time | Lead Adaptor; IS01 Port Pin Plug; Sprint Lead; Sprint Fidelis; Sprint Quattro Lead; Sprint Quattro Secure Lead; Subcutaneous Defibrillation Lead; Y Adaptor; and Transvene SVC Lead | Medtronic, Inc. Minneapolis, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P930014/S039 3/29/10 Real-Time | AcrySert® C Delivery System with the Acrysof® Intraocular Lens (IOL) | Alcon Laboratories Fort Worth, TX 76134 | Approval for the AcrySert® C Delivery System with the Acrysof® IQ IOL Model SN6CWS. |
| P930016/S032 3/9/10 180-Day | STAR S4 and STAR S4 IR Excimer Laser Sytems with Variable Spot Scanning (VSS™) | AMO Manufacturing USA, LLC Milpitas, CA 95035 | Approval for Software Version 4.70 (STAR S4) and Version 5.30 (STAR S4 IR). |
| P950009/S010 3/15/10 180-Day | BD FocalPoint GS Imaging System | BD Diagnostics Diagnostic Systems-Tripath Burlington, NC 27215 | Approval for a manufacturing site located at Tripath Imaging, Inc. in Melbane, North Carolina. |
| P950020/S035 3/18/10 135-Day | Coronary Flextome Cutting Balloon | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for a change in a manufacturing inspection process. |
| P950024/S018 3/16/10 Real-Time | CapSure EPI Unipolar Lead; CapSure EPI Bipolar Lead | Medtronic, Inc. Minneapolis, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P960009/S075 3/4/10 Real-Time | Deep Brain Stimulation Therapy | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for the reformulation of the hotmelt adhesive used for the Medtronic Neuromodulation sterile barrier blister packages. |
| P960040/S213 3/12/10 Real-Time | Cognis/Teligen Family of Devices | Boston Scientific Corporation St. Paul, MN 55112 | Approval for the Second supplier with a design change for the capacitors used in the Cognis/Teligen family of devices. |
| P960058/S082 3/30/10 180-Day | Harmony HiResolution Bionic Ear System | Advanced Bionics, LLC Sylmar, CA 91342 | Approval for a new version of fitting software, called SoundWave 1.6. |
| P970004/S077 3/3/10 Real-Time | Medtronic InterStim® Therapy for Urinary Control | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for the reformulation of the hotmelt adhesive used for Medtronic Neuromodulation sterile barrier blister packages. |
| D970012/S072 3/23/10 Real-Time | AMS 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 | Approval for modifications to the reservoir component (i.e., the Conceal™ Low Profile Reservoir) and associated labeling changes. |
| D970012/S074 3/11/10 Special | AMS 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 | Approval for the addition of an additional inspection during the final manufacturing of the device. |
| P970013/S031 3/16/10 Real-Time | All Families of Pulse Generators, ICDs and CRTs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for version 8.1.1 Model 3330 Software for the Model 3650 Merlin Patient Care System. |
| P970018/S019 3/11/10 | BD PREPSTAIN™ System | Becton Dickinson & Company Franklin Lakes, NJ 07417 | Approval to change the design of the DiTi (Disposable Tip) Cone of the PrepStain instrument. The device, as modified, will be marketed under the trade name BD PREPSTAIN™ System (formerly AutoCyte®PREP System) and is indicated for liquid-based thin layer cell preparation process. The PREPSTAIN system produces SurePath slides (formerly AutoCyte®PREP Slides) that are intended as replacement for conventional gynecologic Pap smears. SurePath slides are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by the Bethesda System for Reporting Cervical/Vaginal Cytologic diagnoses. SurePath® Preservative Fluid is an appropriate collection and transportation medium for gynecologic specimens tested with BD ProbeTec™ Chlamydia trachomatis (CT) Q x (CTQ) and Neisseria gonorrhoeae (GC) Q x (GCQ) Amplified DNA Assays. |
| P970031/S027 3/15/10 135-Day | Freestyle® Aortic Root Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Approval for a change in tissue suppliers. |
| P970034/S014 3/12/10 135-Day | Ultraviolet-Absorbing Posterior Chamber Intraocular Lenses | Aaren Scientific, Inc. Ontario, CA 91761 | Approval for parameter changes in the sterilization cycle. |
| P980016/S221 3/16/10 Real-Time | CapSure Fix Lead | Medtronic, Inc. Minneapolis, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P980022/S031 3/10/10 180-Day | Paradigm REAL-Time Insulin Infusion Pumps, CareLink™ Pro, and CareLink™ Personal Therapy Management Software for Diabetes | Medtronic, Inc. Diabetes Northridge, CA 91325 | Approval for the software modifications for model MMT-523, MMT-723, MMT-523K, and MMT-723K Paradigm REAL-Time insulin pumps as well as new versions of CareLink Pro and CareLink Personal accessory software that have been updated to support these insulin pump models. |
| P980035/S155 3/31/10 180-Day | AT500, Model P1501DR EnRhythm, Model 7276 GEM III | Medtronic, Inc. Mounds View, MN 55112 | Approval of the post-approval study protocol. |
| P980043/S023 3/15/10 135-Day | Hancock® II Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Approval for a change in tissue suppliers. |
| P980050/S044 3/31/10 180-Day | AT500, Model P1501DR EnRhythm, Model 7276 GEM III | Medtronic, Inc. Mounds View, MN 55112 | Approval of the post-approval study protocol. |
| P980050/S045 3/16/10 Real-Time | CS-SVC Transvene LeadCapSure Fix Lead | Medtronic, Inc. Minneapolis, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P990009/S029 3/25/10 Special | Floseal Hemostatic Matrix | Baxter Healthcare Corporation McGaw Park, IL 60085 | Approval to add a warning to the labeling to address the potential risk to users and patients if single use devices are reused. |
| P990034/S015 3/4/10 Real-Time | Medtronic IsoMed® Pump and Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for the reformulation of the hotmelt adhesive used for Medtronic Neuromodulation sterile barrier blister packages. |
| P990064/S030 3/15/10 135-Day | Mosaic® Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Approval for a change in tissue suppliers. |
| P000025/S044 3/26/10 135-Day | COMBI 40+ Cochlear Implant System | MED-EL Corporation Durham, NC 27713 | Approval for a manufacturing process change and an equipment change designed to improve an existing manufacturing step performed in MED-EL implant manufacturing. |
| P010012/S233 3/12/10 Real-Time | Cognis/Teligen Family of Devices | Boston Scientific Corporation St. Paul, MN 55112 | Approval for the Second supplier with a design change for the capacitors used in the Cognis/Teligen family of devices. |
| P010014/S024 3/17/10 135-Day | Oxford® Meniscal Unicompartmental Knee System | Biomet, Inc. Warsaw, IN 46581 | Approval for new heating equipment being introduced to seal blister packages, which contain the Oxford® Partial Knee implants. |
| P010014/S026 3/29/10 Real-Time | Oxford Meniscal Unicompartmental Knee System | Biomet, Inc. Warsaw, IN 46581 | Approval for the addition of the Oxford Partial Knee Twin Peg Femorals which incorporate rounded anterior corners in comparison to the Oxford Knee Femoral Component with 2 Pegs. |
| P010027/S003 3/12/10 135-Day | Anterior Chamber Intraocular Lenses | Aaren Scientific, Inc. Ontario, CA 91761 | Approval for parameter changes in the sterilization cycle. |
| P020018/S034 3/31/10 Special | Zenith Flex® Endovascular Graft | Cook, Inc. Bloomington, IN 47402 | Approval for the addition of manufacturing instructions to assure that the proximal trigger wire is not inadvertently attached to both trigger knobs of the delivery system. |
| P020026/S071 3/31/10 135-Day | Cypher Sirolimus-Eluting Coronary Stent | Cordis Corporation Miami Lakes, FL 33014 | Approval for the addition of a new contractor for quality control testing. |
| P020026/S073 3/18/10 135-Day | CYPHER Sirolimus-Eluting Coronary Stent on RAPTOR Over-the-Wire Delivery System or RAPTORRAIL Rapid Exchange Delivery System | Cordis Corporation Miami, FL 33102 | Approval for a change in environmental conditions for the crimp and pack process. |
| P020026/S074 3/18/10 Special | CYPHER Sirolimus-Eluting Coronary Stent on RAPTOR Over-the-Wire Delivery System or RAPTORRAIL Rapid Exchange Delivery System | Cordis Corporation Miami, FL 33102 | Approval for updates to the Instructions for Use. |
| P030035/S059 3/16/10 Real-Time | All Families of Pulse Generators, ICDs and CRTs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for version 8.1.1 Model 3330 Software for the Model 3650 Merlin Patient Care System. |
| P030036/S014 3/16/10 Real-Time | SelectSecure Lead | Medtronic, Inc. Minneapolis, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P030050/S005 3/5/10 180-Day | Sculptra® Aesthetic (injectable poly-L-lactic acid) | Sanofi Aventis U.S. Bridgewater, NJ 08807 | Approval of the post-approval study protocol. |
| P030054/S135 3/16/10 Real-Time | All Families of Pulse Generators, ICDs and CRTs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for version 8.1.1 Model 3330 Software for the Model 3650 Merlin Patient Care System. |
| P030054/S139 3/3/10 Real-Time | Epic HF CRT-D System | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for Merlin@home Model EX2000 Version 4.5 software. |
| P040033/S015 3/9/10 Real-Time | Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics Memphis, TN 38116 | Approval for the addition of surgical instruments for use with the BHR System and an update to the surgical technique to reflect the new surgical instruments. |
| P040043/S031 3/23/10 180-Day | GORE TAG Thoracic Endoprosthesis 45mm diameter | W.L. Gore & Associated, Inc. Flagstaff, AZ 86001 | Approval for adding the 45mm TAG Thoracic Endoprosthesis to the already existing TAG Thoracic Endoprosthesis product family. The TAG Device is indicated for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy, including adequate iliac/ femoral access, aortic inner diameter in the range of 23-42mm, and ≥2cm non-aneurysmal aorta proximal and distal to the aneurysm. |
| P040044/S027 3/24/10 Special | Mynx® Vascular Closure Device | AccessClosure, Inc. Mountain View, CA 94043 | Approval for labeling changes. |
| P050023/S027 3/5/10 135-Day | Lumax Family of ICDs | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for a change in the supplier of raw materials used to manufacture batteries. |
| P050048/S002 3/12/10 Real-Time | BioRad MONOLISA™ Anti-HBs EIA | Bio-Rad Laboratories Redmond, WA 98052 | Approval for the MONOLISA™ Anti-HBs EIA package insert in order to add the statement that allows storage of the Working Conjugate Solution at room temperature for 30 hours, with up to 10 cycles of 3 hours at room temperature allowed. |
| P070006/S003 3/4/10 Real-Time | T-SPOT®.TB Test | Oxford Immunotec, Ltd. Toms River, NJ 08754 | Approval for the institution of the use of semi-automated system for the dispensing and capping stages in the production of the Positive Control, Panel A Reagent, and Panel B Reagent of the T-SPOT®.TB Test kit using the FF30 dispenser/capper from Flexicon. In addition, the type of vial caps has been changed from a Popcan cap to a HDPE cap which is now gamma irradiated rather than autoclaved to reduce bacterial and fungal contamination. |
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 |
|---|---|---|---|
| P810046/S234 3/26/10 | Voyager® NC Coronary Dilatation Catheter | Abbott Vascular, Inc. Temecula, CA 92591 | Change in irradiation equipment. |
| P840001/S147 3/3/10 | Spinal Cord Stimulation Quadripolar Extension Kit | Medtronic Neuromodulation Minneapolis, MN 55432 | Addition of a second laser welding workstation and power supply. |
| P840001/S148 3/3/10 | Spinal Cord Stimulation® Therapy | Medtronic Neuromodulation Minneapolis, MN 55432 | Cleaning of piece parts in a new Controlled Environment Area (CEA) within the same existing facility. |
| P860004/S121 3/3/10 | SynchroMed® Pump and Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 | Cleaning of piece parts in a new Controlled Environment Area (CEA) within the same existing facility. |
| P860004/S122 3/5/10 | SynchroMed Infusion Systems | Medtronic Neuromodulation Minneapolis, MN 55432 | New inspection steps and molding equipment used in the manufacture of the sutureless connector proximal catheter that is included in models 8709SC, 8731SC, and 8596SC. |
| P860019/S250 3/1/10 | PTCA Catheters | Boston Scientific Corporation Maple Grove, MN 55311 | Addition of an alternate component supplier. |
| P880086/S185 3/5/10 | Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical CRMD Sunnyvale, CA 94086 | Alternate suppliers for various discrete components. |
| P900009/S032 3/26/10 | Exogen 4000 Plus – Bone Healing System | Smith & Nephew, Inc. Memphis, TB 38116 | Component manufacturer site change. |
| P910023/S230 3/5/10 | Cadence Family of ICDs | St. Jude Medical CRMD Sunnyvale, CA 94086 | Alternate suppliers for various discrete components. |
| P940015/S017 3/12/10 | Synvisc-One (hylan G-F 20) | Genzyme Corporation Cambridge, MA 02142 | Change to the automated filling process for the Synvisc-One syringes from using the Cozzoli Filler to using the INOVA Vacuum Filler. |
| P940031/S066 3/4/10 | Vigor Family | Boston Scientific Corporation St. Paul, MN 55112 | Addition of a reed switch test at the reed switch component supplier. |
| P950005/S029 3/12/10 | Celsius, EZ Steer | Biosense Webster, Inc. Diamond Bar, CA 91765 | Addition of an alternate supplier for the thermistor temperature sensor used in the manufacture of ablation catheters. |
| P950027/S012 3/28/10 | Hyalgan® | Fidia Farmaceutici S.p.A. Padua, Italy | Addition of a new, fully automated filling and closing machine. |
| P950029/S051 3/12/10 | Symphony SR 2250, Symphony DR 2550, Rhapsody SR 2210, Rhapsody DR 2510, Rhapsody DR 2530 Family of Pacemakers | ELA Medical, Inc. / Sorin Group Plymouth, MN 55441 | Changing from manual to automated cleaning process. |
| P950037/S077 3/12/10 | Setrox S and Dextrus Pacing Leads | Biotronik, Inc. Lake Oswego, OR 97035 | Addition of alternate suppliers for lead spring and external sleeve. |
| P950039/S021 3/18/10 | ThinPrep Processor 2000/3000 | Hologic, Inc. Marlborough, MA 01750 | Alternate vendor for the membrane material for the manufacture of the ThinPrep GYN Filter used in the ThinPrep Processor 2000 and ThinPrep Processor 3000. |
| P960009/S078 3/3/10 | Deep Brain Stimulation Quadripolar Extension Kit | Medtronic Neuromodulation Minneapolis, MN 55432 | Addition of a second laser welding workstation and power supply. |
| P960040/S215 3/4/10 | Teligen and Confient | Boston Scientific Corporation St. Paul, MN 55112 | Addition of an alternate supplier of antenna tubing. |
| P960040/S217 3/4/10 | Ventak Family | Boston Scientific Corporation St. Paul, MN 55112 | Addition of a reed switch test at the reed switch component supplier. |
| D970003/S116 3/4/10 | Insigna and Altrua Families | Boston Scientific Corporation St. Paul, MN 55112 | Addition of a reed switch test at the reed switch component supplier. |
| P970004/S081 3/3/10 | Interstim® Sacral Nerve Stimulation (SNS) Therapy for Urinary Control | Medtronic Neuromodulation Minneapolis, MN 55432 | Cleaning of piece parts in a new Controlled Environment Area (CEA) within the same existing facility. |
| P970008/S047 3/31/10 | Targis® System for the Treatment of BPH | Urologix, Inc. Minneapolis, MN 66447 | Removal of a quality control test on an incoming raw material component used in the manufacture of the treatment catheter. |
| P970012/S064 3/18/10 | Kappa 400 DR/SR Family of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Change in location of a sterilization system. |
| D970012/S073 3/24/10 | AMS 700® Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 | Implementation of a new, duplicate mold for a component of the pump assembly. |
| P970018/S020 3/8/10 | BD PrepStain™ System | BD Diagnostics Durham, NC 27703 | Replace the off-the-shelf vacuum pump with an alternate model to compensate for a change in the supplier. |
| P970054/S008 3/19/10 | Biotrin International’s Parvovirus B19 IgG In Vitro Diagnostic Device | Biotrin International Ltd. Dublin, Ireland | Introduction of a new production procedure to prepare a viral master stock, and the documentation of the tubing priming steps for the plate coating equipment used in the device. |
| P970055/S008 3/19/10 | Biotrin International’s Parvovirus B19 IgM In Vitro Diagnostic Device | Biotrin International Ltd. Dublin, Ireland | New production procedure to prepare a viral master stock, and the documentation of the tubing priming steps for the plate coating equipment used in the device. |
| P980016/S225 3/5/10 | EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Secura, Virtuoso, and Virtuoso II Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Change in a vendor’s epitaxy supplier. |
| P980016/S226 3/5/10 | Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Secura DR/VR, Maximo II DR/VR and Virtuoso II DR/VR Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Change in a vendor’s epitaxy supplier. |
| P980016/S227 3/12/10 | Secura DR/VR, Maximo II DR/VR, and Virtuoso II DR/VR Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Elimination of hybrid screening step. |
| P980016/S228 3/18/10 | GEM II, Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II DR/VR, Virtuoso II DR/VR, Secura DR/VR Family of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Change in location of a sterilization system. |
| P980016/S229 3/19/10 | Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II DR/VR, Virtuoso II DR/VR, Secura DR/VR Family of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Change in how the installation and configuration of the application software for the automated accelerometer test system was controlled. |
| P980018/S008 3/8/10 | HercepTest™ | Dako Denmark A/S Glostrup, Denmark DK-2600 | Change in the manufacturing filling process to increase the reagent fill volume to address shortage concerns. |
| P980022/S070 3/26/10 | SOF-SENSOR Glucose Sensors | Medtronic MiniMed Northridge, CA 91325 | Change from a manual process to an automated singultation machine. |
| P980023/S039 3/12/10 | Linox S and Linox SD ICD Leads | Biotronik, Inc. Lake Oswego, OR 97035 | Addition of alternate suppliers for lead spring and external sleeve. |
| P980035/S158 3/18/10 | Kappa 600/700, 650, 800/900, Relia, Sigma, Medtronic 350, EnPulse, EnRhythm, AT500, Adapta, Versa, and Sensia Family of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Change in location of a sterilization system. |
| P980035/S159 3/19/10 | Kappa 600/700, 650, 800/900; Relia; Sigma; EnPulse; EnRhythm; and Adapta/Versa/ Sensia Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Change in how the installation and configuration of the application software for the automated accelerometer test system was controlled. |
| P980040/S032 3/19/10 | TECNIC® Multifocal One-Piece Intraocular Lens (IOL) | Abbott Medical Optics, Inc. Santa Ana, CA 92705 | Addition of an alternate cryotumbling procedure. |
| P980049/S054 3/12/10 | Ovatio VR 6250, Ovatio DR 6550 Family of Implantable Cardioverter Defibrillators | ELA Medical, Inc. / Sorin Group Plymouth, MN 55441 | Changing from manual to automated cleaning process. |
| P990001/S061 3/18/10 | Clarity DDDR, Clarity SSIR, Diamond III, Rugby III, Topaz III, Jade III, Vita 2 DDDR, C-Series, and T-Series Family of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Change in location of a sterilization system. |
| P990001/S062 3/19/10 | C-series and T-series IPGs | Medtronic, Inc. Mounds View, MN 55112 | Change in how the installation and configuration of the application software for the automated accelerometer test system was controlled. |
| P990025/S023 3/4/10 | NaviStar, NaviStar RMT, EZ Steer Nav, QwikStar | Biosense Webster, Inc. Diamond Bar, CA 91765 | Addition of an alternate supplier for the mu-shield used in the manufacture of the navigational catheters. |
| P990025/S024 3/12/10 | NaviStar, EZ Steer Nav, QwikStar | Biosense Webster, Inc. Diamond Bar, CA 91765 | Addition of an alternate supplier for the thermistor temperature sensor used in the manufacture of ablation catheters. |
| P000012/S023 3/8/10 | COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 | Elimination of functional testing at the incoming raw material stage for a kit component used in the device. |
| P000012/S024 3/24/10 | COBAS Amplicor HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 | Clean In Place (CIP) cycle changes and minor equipment modifications for the Scale Bulk formulation tanks and their associated filling transfer lines. |
| P000029/S064 3/18/10 | Deflex® Injectable Gel | Oceana Therapeutics, Inc. Edison, NJ 08817 | Alternate supplier of solutions used as ingredients in the bulk manufacturing process for pH adjustment and gel stabilization. |
| P000036/S007 3/26/10 | Dermagraft® | Advanced BioHealing, Inc. LaJolla, CA 92037 | Removal of the in process assay from the Dermagraft® manufacturing process. |
| P010012/S235 3/4/10 | Renewal 3 RF, Livian, and Cognis | Boston Scientific Corporation St. Paul, MN 55112 | Addition of an alternate supplier of antenna tubing. |
| P010015/S079 3/18/10 | InSync and InSync III Family of CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 | Change in location of a sterilization system. |
| P010015/S080 3/19/10 | InSync III CRT-P | Medtronic, Inc. Mounds View, MN 55112 | Change in how the installation and configuration of the application software for the automated accelerometer test system was controlled. |
| P010019/S014 3/24/10 | Lotrafilcon Soft Contact Lenses for Extended Wear | Ciba Vision Corporation Duluth, CA 30097 | Alternate inspection system for optical tools. |
| P010025/S018 3/4/10 | Selenia FFDM System Full Field Digital Mammography System | Hologic, Inc. Danbury, CT 06810 | Change in device software management. |
| P010031/S184 3/5/10 | Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, and Maximo II Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Change in a vendor’s epitaxy supplier. |
| P010031/S185 3/5/10 | InSync II Protect, InSync Sentry, InSync Marquis, and InSync Maximo Families of ICDs, Concerto, Consulta, Maximo II, and Concerto II Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Change in a vendor’s epitaxy supplier. |
| P010031/S186 3/12/10 | Consulta, Maximo II, and Concerto II Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Elimination of hybrid screening step. |
| P010031/S187 3/18/10 | InSync, InSync Marquis, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync III Protect, InSync Sentry, InSync Maximo Family of ICDs; Concerto, Concerto II, Maximo II, Consulta Family of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Change in location of a sterilization system. |
| P010031/S188 3/19/10 | InSync III Marquis, InSync III Protect, InSync Sentry, and InSync Maximo Families of ICDs; Concerto, Concerto II, Maximo II, and Consulta Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Change in how the installation and configuration of the application software for the automated accelerometer test system was controlled. |
| P010068/S019 3/4/10 | NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS, QwikStar DS | Biosense Webster, Inc. Diamond Bar, CA 91765 | Addition of an alternate supplier for the mu-shield used in the manufacture of the navigational catheters. |
| P020009/S060 3/1/10 | Express®/ Express 2® Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Addition of an alternate component supplier. |
| P020036/S017 3/17/10 | SMART® Nitinol Stent and SMART® Control Nitinol Stent System | Cordis Corporation Miami Lakes, FL 33014 | Change in packaging configuration. |
| P020049/S002 3/23/10 | ProCol® Vascular Bioprosthesis | Hancock Jaffe Laboratories Irvine, CA 92614 | Addition of a new distribution site. |
| P030005/S061 3/4/10 | Contak Renewal TR Family | Boston Scientific Corporation St. Paul, MN 55112 | Addition of a reed switch test at the reed switch component supplier. |
| P030009/S040 3/31/10 | Driver & Micro-Driver Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 | Addition of an alternate laser for a manufacturing process. |
| P030025/S083 3/1/10 | TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent | Boston Scientific Corporation Maple Grove, MN 55311 | Addition of an alternate component supplier. |
| P030025/S084 3/26/10 | TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent | Boston Scientific Corporation Maple Grove, MN 55311 | Change to the acceptance criteria and testing method of the stent protector. |
| P030031/S026 3/4/10 | NaviStar ThermoCool, NaviStar RMT ThermoCool, EZ Steer ThermoCool Nav | Biosense Webster, Inc. Diamond Bar, CA 91765 | Addition of an alternate supplier for the mu-shield used in the manufacture of the navigational catheters. |
| P030031/S027 3/12/10 | Celsius ThermoCool, NaviStar ThermoCool | Biosense Webster, Inc. Diamond Bar, CA 91765 | Addition of an alternate supplier for the thermistor temperature sensor used in the manufacture of ablation catheters. |
| P030035/S066 3/5/10 | Frontier/Frontier II Family of CRT-Ps | St. Jude Medical CRMD Sunnyvale, CA 94086 | Alternate suppliers for various discrete components. |
| P030040/S007 3/16/10 | ADVIA Centaur HBc IgM Assay | Siemens Healthcare Diagnostics E. Walpole, MA 02032 | Alternate supplier for a critical raw material used in the production of the assay Lite Reagent. |
| P030047/S020 3/17/10 | Cordis PRECISE®, PRECISE® RX, and PRECISE® PRO Rx Nitinol Stent System | Cordis Corporation Miami Lakes, FL 33014 | Change in packaging configuration. |
| P030054/S145 3/5/10 | Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical CRMD Sunnyvale, CA 94086 | Alternate suppliers for various discrete components. |
| P040014/S013 3/23/10 | Therapy Cardiac Ablation Catheter, Therapy 4mm Thermistor and Therapy Bi-Directional Catheters | St. Jude Medical Irvine, CA 92614 | Addition of a larger sterilization chamber. |
| P040016/S053 3/1/10 | VeriFLEX™ (Liberté®) Bare Metal Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Addition of an alternate component supplier. |
| P040024/S046 3/31/10 | Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85256 | Changes to the packaging equipment for the device. |
| P040036/S019 3/4/10 | NaviStar ThermoCool, NaviStar RMT ThermoCool, EZ Steer ThermoCool Nav | Biosense Webster, Inc. Diamond Bar, CA 91765 | Addition of an alternate supplier for the mu-shield used in the manufacture of the navigational catheters. |
| P040036/S020 3/12/10 | Celsius ThermoCool, NaviStar ThermoCool | Biosense Webster, Inc. Diamond Bar, CA 91765 | Addition of an alternate supplier for the thermistor temperature sensor used in the manufacture of ablation catheters. |
| P040042/S018 3/23/10 | Therapy Dual 8, Therapy 8 mm Thermistor, and Safire TX Ablation Catheters | St. Jude Medical Irvine, CA 92614 | Addition of a larger sterilization chamber. |
| P040044/S026 3/17/10 | Mynx Vascular Closure Device | Access Closure Mountain View, CA 94043 | Addition of a new adhesive and associated manufacturing equipment. |
| P040044/S028 3/31/10 | Mynx Vascular Closure Device | Access Closure, Inc. Mountain View, CA 94043 | Modification of lot release testing. |
| P040045/S011 3/12/10 | VISTAKON® (senofilcon A) Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 | Change in a quality control test method for the finished device. |
| P040047/S016 3/11/10 | Coaptite® Injectable Implant | Bioform Medical, Inc. Franksville, WI 53126 | Change to the environmental conditions in the clean room. |
| P050037/S022 3/12/10 | Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville, WI 53126 | Evaluation for the clean room. |
| P050052/S025 3/12/10 | Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville, WI 53126 | Evaluation for the clean room. |
| P060006/S007 3/1/10 | Express® SD Renal Monorail® Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Addition of an alternate component supplier. |
| P060008/S043 3/1/10 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent | Boston Scientific Corporation Maple Grove, MN 55311 | Addition of an alternate component supplier. |
| P060008/S044 3/26/10 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent | Boston Scientific Corporation Maple Grove, MN 55311 | Change to the acceptance criteria and testing method of the stent protector. |
| P060019/S011 3/23/10 | Therapy Cool Path Ablation Catheters | St. Jude Medical Irvine, CA 92614 | Addition of a larger sterilization chamber. |
| P060027/S020 3/4/10 | Paradym CRT-D | ELA Medical, Inc./Sorin Group Plymouth, MN 55441 | Addition of a new laser welding source and controlled atmosphere fixture. |
| P060027/S021 3/12/10 | Ovatio CRT-D 6750 Cardiac Resynchronization Therapy Defibrillators | ELA Medical, Inc. / Sorin Group Plymouth, MN 55441 | Changing from manual to automated cleaning process. |
| P060030/S009 3/24/10 | COBAS Ampliprep/ COBAS Taqman HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 | Clean In Place (CIP) cycle changes and minor equipment modifications for the Scale Bulk formulation tanks and their associated filling transfer lines. |
| P060033/S050 3/31/10 | Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 | Addition of an alternate laser for a manufacturing process. |
| P070006/S004 3/19/10 | T-SPOT®.TB Test | Oxford Immunotec, Ltd. Oxfordshire, United Kingdom OX14 4RY | Additional suppliers (US Biological, Inc.) of phytohemagglutinin and (Thermo Fisher Scientific GmbH) of antigen peptides for the T-SPOT®.TB kits. |
| P070015/S032 3/4/10 | XIENCE V™ and PROMUS™ Everlolimus-Eluting Coronary Stent Systems (EECSS) | Abbott Vascular Temecula, CA 92591 | Addition of an upgraded packaging sealer. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 61
Summary of PMA Originals Under Review
Total Under Review: 82
Total Active: 36
Total On Hold: 46
Number Greater Than 180 Days: 6
Summary of PMA Supplements Under Review
Total Under Review: 570
Total Active: 373
Total On Hold: 197
Number Greater Than 180 Days: 18
Summary of All PMA Submissions Received
Originals: 4
Supplements: 97
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 61
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 119.8
FDA Time: 93.7 Days MFR Time: 26.1 Days
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