Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. 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. Information about the PDF Reader is available.
PMA Original Approvals
| P020012 10/27/06 |
ArteFill | Artes Medical USA, Inc. San Diego , CA 92121 |
Approval for the ArteFill, which is indicated for correction of nasolabial folds. |
| P040050 10/30/06 |
Macroplastique® Implants | Uroplasty, Inc. Minneapolis , MN 55413 |
Approval for Macroplastique® Implants. The device is indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD). |
| P050025 10/27/06 |
Endotex® Nexstent® Carotid Stent and Delivery System and Endotex® Carotid Stent and Monorail® Delivery System | Endotex Interventional Systems, Inc. Cupertino , CA 95014 |
Approval for the Endotex NexStent®. This device is indicated for t reatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below: 1) Patients with neurological symptoms and ≥50% stenosis of the common or internal carotid artery by duplex ultrasound or angiogram OR patients without neurological symptoms and ≥80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND 2) Patients must have a reference vessel diameter within the range of 4mm and 9mm at the target lesion and a stenosis less than 30mm in length. |
PMA Supplemental Approvals
| N18033/S040 10/31/06 Real-Time |
Vistakon® (etafilcon A) Soft (hydrophilic) Contact Lenses, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker | Vistakon®, A Division of Johnson & Johnson Vision Care, Inc. Jacksonville , FL 32256 |
Approval for adding polyvinylpyrroli-done (Providone) to the packing solution for the device. |
| P830045/S103 10/20/06 Real-Time |
Paragon/Phoenix Family of Pacemakers | St. Jude Medical Sylmar , CA |
Approval for Model 3330 Version 5.0 software for use on the Model 3650 Merlin Patient Care System. |
| P850020/S024 10/19/06 Special |
PROSORBA® Column | Fresenius Medical Care Lexington , MA 02420 |
Approval for labeling changes to add 1) caution and precaution statements relating to the risk of thrombosis, 2) a clarification regarding treatment volumes for idiopathic thrombocytopenic purpura (ITP) patients, 3) a clarification that ITP, as well as rheumatoid arthritis, patients may not feel the effects of PROSORBA® treatments immediately after initiation of therapy, and 4) a clarification that treatments should begin within one hour of priming. |
| P880006/S046 10/20/06 Real-Time |
Sensolog/Dialog/ Regency Family of Pacemakers | St. Jude Medical Sylmar , CA |
Approval for Model 3330 Version 5.0 software for use on the Model 3650 Merlin Patient Care System. |
| P880086/S133 10/20/06 Real-Time |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical Sylmar , CA |
Approval for Model 3330 Version 5.0 software for use on the Model 3650 Merlin Patient Care System. |
| P880086/S134 10/27/06 Real-Time |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical Sylmar , CA |
Approval for an alternate feedthrough substrate on the Victory family of pacemakers and ICD’s. |
| P890003/S109 10/20/06 Special |
CareLink Monitors 2490H, and Model 2020A CardioSight Reader | Medtronic, Inc. Shoreview , MN 55126 |
Approval for electrical safety instructions for the CareLink Monitor. |
| P890055/S019 10/19/06 Real-Time |
Codman 3000 Pump Silicone Catheter | Codman & Shurtleff, Inc. Raynham , MA 02767 |
Approval to change the material of the three silicone beads attached to the distal end of the pump catheter during manufacture to a different silicone, NuSil MED-4850 (SSF-MLTN-850 45-55). |
| P910023/S121 10/20/06 Real-Time |
Cadence Family of ICDs | St. Jude Medical Sylmar , CA |
Approval for Model 3330 Version 5.0 software for use on the Model 3650 Merlin Patient Care System. |
| P910023/S122 10/27/06 Real-Time |
Cadence Family of ICDs | St. Jude Medical Sylmar , CA |
Approval for an alternate feedthrough substrate on the Victory family of pacemakers and ICD’s. |
| P910066/S022 10/13/06 180-Day |
OL1000/OL1000 SC and SpinaLogic Bone Growth Stimulator | DJO, LLC Vista , CA 92081 |
Approval for a manufacturing site located in Vista, California. |
| P930038/S046 10/5/06 180-Day |
Angio-Seal™ Vascular Closure Device | St. Jude Medical Minnetonka , MN 55345 |
Approval to remove the current precaution pertaining to patients with peripheral vascular disease (PVD) from the Special Patient Populations section and add a precaution to te Procedure section, identifying published clinical experience of patients with PVD. |
| P950039/S017 10/5/06 Special |
ThinPrep 2000 System | Cytyc Corporation Marlborough , MA 01752 |
Approval for labeling changes regarding warning and handling/disposal instructions for ThinPrep 2000 processors that have been contaminated with transmissible spongiform encephalopathy (TSE). |
| P960009/S040 10/5/06 Real-Time |
Model 7482 Extension Kit | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for replacing the existing tunneling tools with a new modified version. |
| P960013/S022 10/10/06 Real-Time |
Locator Plus Deflectable Stylets | St. Jude Medical CRMD Sylmar , CA 91342 |
Approval for the Locator Plus family of deflectable stylets, models 1281, 1282, 1283, 1291, 1292 and 1293. The Locator Plus stylets are similar to the approved Locator Model 4036 steerable stylet (PMA P960013/S010), but with six different combinations of tip radii and straight tip lengths. The Locator Plus family of deflectable stylets are intended for use when implanting compatible St. Jude Medical active fixation straight endocardial pacemaker leads, Tendril Model 1688 SDX and higher. |
| P970003/S071 10/17/06 Real-Time |
VNS Therapy™ System | Cyberonics, Inc. Houston , TX 77058 |
Approval for the following changes to the labeling harmonization and modularization for physician pulse generator and lead labeling: 1) The addition of a manual entitled, “Revision/Replacement/Removal Procedure Manual”. 2) The incorporation of the physician’s manual for the Model 303 Lead into the harmonized labeling which includes the addition of the modular physician’s manual entitled, “Technical Information – VNS Therapy™ Perennia™ Model 303 Lead”. 3) Revisions to the “Implantation Procedure” module. |
| P970003/S074 10/31/06 Special |
VNS Therapy™ System | Cyberonics, Inc. Houston , TX 77058 |
Approval for the addition of a precaution to the Model 250 Programming Software Physician’s Manual v.6.1 and Model 250 Programming Software Physician’s Manual v.7.0 in three different places in each of the respective manuals. |
| P970013/S013 10/20/06 Real-Time |
Microny Family of Pacemakers and Pacemaker Programmers | St. Jude Medical Sylmar , CA |
Approval for Model 3330 Version 5.0 software for use on the Model 3650 Merlin Patient Care System. |
| P970053/S009 10/11/06 Panel |
Nidek EC-5000 Excimer Laser System | Nidek Company, LTD Gamagori Aichi , Japan |
Approval for the Nidek EC-5000 Excimer Laser System. The device uses a 6.0 mm optical zone and a 9.0 mm treatment zone and is indicated for laser assisted in-situ keratomileusis (LASIK): 1) for the reduction or elimination of hyperopia refractive errors from +0.5 to +5.0 D of sphere with or without astigmatic refractive errors from +0.5 to +2.0 D at the spectacle plane with manifest refraction spherical equivalent (MRSE) of +5.0 D or less; 2) in patients 21 years of age or older; and 3) in patients with documented stability of manifest refraction over the prior year, demonstrated by a change in MRSE not greater than +/- 0.50 diopter. |
| P980016/S085 10/20/06 Special |
GEM DR , GEM II DR and VR, GEM III DR and VR, Onyx, Marquis DR and VR, Maximo DR and VR, Intrinsic and Intrinsic 30 Implantable Devices | Medtronic, Inc. Shoreview , MN 55126 |
Approval for electrical safety instructions for the CareLink Monitor. |
| P980022/S016 10/16/06 180-Day |
Paradigm® Real Time – MMT-522/722 Insulin Pump | Medtronic MiniMed Northridge , CA 91325 |
Approval for a manufacturing site located at Medtronic MiniMed Puerto Rico Operations, Juncos, Puerto Rico. |
| P980035/S062 10/20/06 Special |
Kappa 600/700/800/900 and EnPulse Families of Pacemakers | Medtronic, Inc. Shoreview , MN 55126 |
Approval for electrical safety instructions for the CareLink Monitor. |
| P990004/S010 10/3/06 Real-Time |
Surgifoam® Absorbable Gelatin Sponge, USP, Oral Sponge | Johnson & Johnson Wound Management a division of Ethicon, Inc. Somerville , NJ 08876 |
Approval for an oral surgery form of Surgifoam® Absorbable Gelatin Sponge, USP. The device, as modified, will be marketed under the trade name Surgifoam® Absorbable Gelatin Sponge, USP, Oral Sponge and is indicated for use as an adjunct to hemostasis during surgical procedures. |
| P990025/S012 10/6/06 180-Day |
Navistar 4 mm Bi-Directional Diagnostic/Ablation Catheters | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for using a new handle, puller wires and 1 mm location sensor. |
| P990033/S008 10/5/06 180-Day |
PepGen P-15 Dental Bone Grafting Material with Biologic Component | Dentsply International York , PA 17405 |
Approval for a manufacturing site located at Sterigenics, US, LLC, Queensbury, New York, to perform the Ethylene oxide sterilization. |
| P990052/S012 10/13/06 180-Day |
Vibrant® Soundbridge® Middle Ear Implant System | Med-El Corporation Durham , NC 27713 |
Approval for a manufacturing site located at Med-El Elektromedizinische Gerate (contract manufacturer for Vibrant Med-El) GmbH of Innsbruck, Austria, for the laser welding of the pre welded Demodulator unit and the Bobbin. |
| P990056/S004 10/13/06 Real-Time |
Elecsys Total PSA Immunoassay | Roche Diagnostics Corp. Indianapolis , IN 46250 |
Approval for modifications to the package insert which includes modification of the equimolarity statement found in the Summary Section, addition of LoB/LoD information and minor editorial revisions. |
| P000043/S016 10/13/06 180-Day |
TherMatrx® Office Thermo Therapy™ System | American Medical Systems Minnetonka , MN 55343 |
Approval for a manufacturing site located at MRI Manufacturing and Research, Inc., Tucson, Arizona to conduct packaging and labeling for the Rx-200 Applicator (catheter). |
| P000053/S005 10/13/06 180-Day |
Sphincter 800™ Urinary Control System | American Medical Systems Minnetonka , MN 55343 |
Approval for the addition of InhibiZone™ Treatment to components of the Sphincter 800™ Urinary Control System, specifically the cuffs, pumps, and kink resistant tubing. |
| P010013/S017 10/5/06 135-Day |
NovaSure Impedance Controlled Endometrial Ablation System | Cytyc Surgical Products Mountain View , CA 94041 |
Approval for a change in supplier of the first stage CO 2 regulator for the NovaSure’s Cavity Integrity Assessment System. |
| P010031/S052 10/20/06 Special |
InSync Marquis, InSync Maximo, InSync Sentry and InSync II Marquis Implantable Devices | Medtronic, Inc. Shoreview , MN 55126 |
Approval for electrical safety instructions for the CareLink Monitor. |
| P020014/S010 10/11/06 180-Day |
Essure™ System | Conceptus, Inc. Mountain View , CA 94041 |
Approval for modification of the Essure Physician and Patient labeling to include information on the results of the Postapproval Study for Newly Trained Physicians. |
| P020016/S002 10/13/06 180-Day |
Total Temporomandibular Joint Replacement System | Walter Lorenz Surgical, Inc. Jacksonville , FL 32218 |
Approval for a manufacturing site located at Arthrotek, Inc.’s Ontario California, facility for the purchase of raw material for the mandibular blanks; the cutting of this raw material; and the addition of another Wire Electrical Discharge Machine. |
| P030025/S013 10/19/06 180-Day |
TAXUS Express 2™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for a revision particulate testing method and revising regulatory and batch release particulate specifications. |
| P030035/S024 10/20/06 Real-Time |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical Sylmar , CA |
Approval for Model 3330 Version 5.0 software for use on the Model 3650 Merlin Patient Care System. |
| P030035/S025 10/27/06 Real-Time |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical Sylmar , CA |
Approval for an alternate feedthrough substrate on the Victory family of pacemakers and ICD’s. |
| P030036/S002 10/11/06 Special |
SelectSecure Lead Model 3830 | Medtronic, Inc. Cardiac Rhythm Management Shoreview , MN 55126 |
Approval or a label change to the Technical Manual for the SelectSecure Lead Model 3830. |
| P030054/S040 10/20/06 Real-Time |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Sylmar , CA |
Approval for Model 3330 Version 5.0 software for use on the Model 3650 Merlin Patient Care System. |
| P030054/S041 10/27/06 Real-Time |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Sylmar , CA |
Approval for an alternate feedthrough substrate on the Victory family of pacemakers and ICD’s. |
| P040012/S018 10/2/06 135-Day |
RX ACCULINK® and ACCULINK® Carotid Stent Systems | Guidant Corporation Santa Clara , CA 95054 |
Approval for a change in the method of inspecting the ACCULINK stent outer diameter. |
| P040022/S001 10/2/06 135-Day |
Angio link Vascular Closure System | Medtronic Vascular Taunton , MA 02780 |
Approval for various manufacturing process changes to ensure consistency. |
| P040023/S008 10/18/06 Special |
Duraloc Option Ceramic Hip System | DePuy Orthopaedics, Inc. Warsaw , IN 46581 |
Approval for changes to the Warnings and precautions section of the package insert labeling to include additional statements that advise the surgeon to avoid the taper region and shell face of the metal acetabular shell component when impacting the shell to adjust the position of the component. |
| P040027/S003 10/25/06 Special |
GORE VIATORR TIPS | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 |
Approval for changes made to the instruction for use. |
| P040033/S001 10/13/06 Real-Time |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics Memphis , TN 38116 |
Approval for: 1) Addition of intermediate sized femoral head components to the BHR system (40mm, 44mm, 48mm, 52mm and 56mm); 2) Addition of acetabular cups that mate with the intermediate sized femoral head components (standard, dysplasia and bridging); and 3) Revisions to the BHR labeling to reflect the additional intermediate sized components. |
| P040042/S005 10/3/06 Real-Time |
Therapy Dual Catheter and IBI-1500T6 Cardiac Ablation Generator | Irvine Biomedical, Inc. Irvine , CA 92614 |
Approval for the addition of an adapter cable, 1739-W, to allow the Therapy Dual 8 Catheter to be used with the Biosense Webster Stockert 70 RF generator, approved under P990071. |
| P050023/S002 10/30/06 180-Day |
Tupos LV/ATx and Kronos LV-T CRT-Ds and Corox OTW Steroid LV Pacing Lead |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval of the post-approval study for the device. |
30-Day Notices (135 Day Supplement was not required)
| N12159/S021 10/13/06 |
Surgicel/ Surgicel Nu-Knit/ Surgicel Fibrillar Absorbable Hemostat |
Johnson & Johnson Wound Management Worldwide A division of Ethicon, Inc. Somerville , NJ 08876 |
Change of the packaging from Pechiney MARAFLEX #5269 to Pechiney M-1332 and Amcor LPS-451. |
| P830045/S102 10/25/06 |
Paragon/Phoenix Pacemakers | St. Jude Medical Sylmar , CA 91342 |
Automation of downloading Merlin preference files through the Final Software Update process. |
| P860019/S213 10/3/06 |
PTCA Catheters | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Use of a manufacturing fixture in the port pre-assembly process. |
| P860019/S214 10/13/06 |
Maverick PTCA Catheters | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Addition of an alternative method for removing the heat shrink aid. |
| P860019/S215 10/20/06 |
Maverick PTCA Catheters | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Change the laser wattage and beam split ratio for the Maverick PTCA Catheters. |
| P880006/S045 10/25/06 |
Sensolog/Dialog/ Regency Pacemakers | St. Jude Medical Sylmar , CA 91342 |
Automation of downloading Merlin preference files through the Final Software Update process. |
| P880086/S129 10/12/06 |
Identity, Verity, Integrity, Victory, and Affinity Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Adding a test to the IC wafer probe test suite for Victory and Frontier II devices. |
| P880086/S130 10/13/06 |
Victory Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Alternate supplier for the “L” connector sub-assembly. |
| P880086/S131 10/13/06 |
Identity, Verity, Integrity and Victory Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Alternate encapsulation material used in pacemaker hybrid assemblies. |
| P880086/S132 10/25/06 |
Affinity/Integrity/ Victory Pacemakers | St. Jude Medical Sylmar , CA 91342 |
Automation of downloading Merlin preference files through the Final Software Update process. |
| P910023/S117 10/6/06 |
Epic II/II+ DR/VR & Atlas II/II+ DR/VR Implantable Cardioverter Defibrillator Family | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Alternate vendor for the support assembly. |
| P910023/S120 10/25/06 |
Cadence ICDs | St. Jude Medical Sylmar , CA 91342 |
Automation of downloading Merlin preference files through the Final Software Update process. |
| P950020/S019 10/19/06 |
Flextome Cutting Balloon Monorail | Boston Scientific San Diego , CA 92123 |
Change in the sterility dose audit procedures from VD Max to Method 1, with corresponding changes in minimum radiation sterilization dose and the number of quarterly sterilization dose audits. |
| P960028/S015 10/20/06 |
Array® Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lenses | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Change to an automatic coring fixture for silicone intraocular lens loop insertion. |
| P960028/S016 10/18/06 |
CeeOn® Intraocular Lenses | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Change to clean room specifications to improve efficiency, environmental specifications and modifications, and continuous product flow. |
| D970003/S078 10/25/06 |
Pulsar/ Pulsar Max/ Insigia |
Guidant Corporation St. Paul , MN 55112 |
Final Pack test software modification. |
| P970013/S012 10/25/06 |
Microny Pacemakers | St. Jude Medical Sylmar , CA 91342 |
Automation of downloading Merlin preference files through the Final Software Update process. |
| P970051/S039 10/5/06 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Englewood , CO 80112 |
Additional ethylene oxide (EO) sterilizer and change to a new size of ethylene oxide canister. |
| P980040/S008 10/18/06 |
Sensar Soft Acrylic Intraocular Lenses | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Change to clean room specifications to improve efficiency, environmental specifications and modifications, and continuous product flow. |
| P990066/S025 10/20/06 |
Senographe 2000D and DS full Field Digital Mammography Systems | GE Healthcare Milwaukee , WI 53188 |
Addition of GE Healthcare/Finland as an alternate supplier for the x-ray buckys used on the device. |
| P990080/S009 10/18/06 |
Array® Multifocal Intraocular Lenses | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Change to clean room specifications to improve efficiency, environmental specifications and modifications, and continuous product flow. |
| P000015/S008 10/5/06 |
Nucleus 24 Auditory Brainstem Implant System (ABI) | Cochlear Americas Englewood , CO 80112 |
Additional ethylene oxide (EO) sterilizer and change to a new size of ethylene oxide canister. |
| P010012/S140 10/17/06 |
Easytrak 3 IS-1 and LV-1 Heart Failure Leads | Guidant CRM St. Paul , MN 55112 |
Adding an acceptance activity to the manufacturing process. |
| P020009/S030 10/6/06 |
Express 2 Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Change to a paperless laser information system. |
| P020009/S032 10/3/06 |
Express 2 Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Use of a manufacturing fixture in the port pre-assembly process. |
| P020018/S013 10/17/06 |
Zenith® AAA Endovascular Graft and H&L-B One-Shot™ Introduction System | Cook, Inc. Bloomington , IN 47402 |
Transfer the cutting, sandblasting, and chamfering steps used to manufacture the threaded cannula (a component of the H&L-B One-Shot™ Introduction System) from Cook, Inc. to an outside vendor. |
| P020018/S014 10/17/06 |
Zenith® AAA Endovascular Graft and H&L-B One-Shot™ Introduction System | Cook, Inc. Bloomington , IN 47402 |
Allowing the internal and external threads of the dilator tip (a component of the H&L-B One-Shot™ Introduction System) to be machined by an outside vendor. |
| P020018/S015 10/18/06 |
Zenith® AAA Endovascular Graft and H&L-B One-Shot™ Introduction System | Cook, Inc. Bloomington , IN 47402 |
Assembly of raw material kits to facilitate construction of leg extension graft subassemblies, and to allow leg extension graft subassemblies to be produced by a contract manufacturer. |
| P020018/S017 10/2/06 |
Zenith® AAA Endovascular Graft and H&L-B One-Shot™ Introduction System | Cook, Inc. Bloomington , IN 47402 |
Allowing the internal and external threads of the dilator tip (a component of the H&L-B One-Shot™ Introduction System) to be machined by an outside vendor. |
| P020018/S018 10/25/06 |
Zenith® AAA Endovascular Graft and H&L-B One-Shot™ Introduction System | Cook, Inc. Bloomington , IN 47402 |
Alternative method to temporarily attach selected external Z-stents to the graft material prior to permanent sewing. |
| P030025/S036 10/6/06 |
Taxus Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Change to a paperless laser information system. |
| P0300025/S038 10/3/06 |
Taxus Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Use of a manufacturing fixture in the port pre-assembly process. |
| P030025/S040 10/26/06 |
Taxus Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Use of a manufacturing fixture for loading the crimp sheath. |
| P030035/S021 10/13/06 |
Frontier II CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Adding a test to the IC wafer probe test suite for Victory and Frontier II devices. |
| P030035/S022 10/13/06 |
Frontier II Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Alternate encapsulation material used in pacemaker hybrid assemblies. |
| P030035/S023 10/25/06 |
Frontier/Frontier II CRT-Ps | St. Jude Medical Sylmar , CA 91342 |
Automation of downloading Merlin preference files through the Final Software Update process. |
| P030054/S037 10/6/06 |
Epic II HF & Atlas II HF Cardiac Resynchronization Therapy Devices Family | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Alternate vendor for the support assembly. |
| P030054/S039 10/25/06 |
Epic HF/Atlas + HF CRT-Ds | St. Jude Medical Sylmar , CA 91342 |
Automation of downloading Merlin preference files through the Final Software Update process. |
| P040001/S003 10/19/06 |
X-STOP® IPD System | St. Francis Medical Technologies, Inc. Alameda , CA 94501 |
Changes in packaging footprint, packaging processes, labeling processes and manufacturing flow for the device. |
| P040016/S017 10/6/06 |
Liberté MR and OTW Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Change to a paperless laser information system. |
| P060003/S002 10/4/06 |
AxSYM® AUSAB® | Abbott Laboratories Diagnostics Division Abbott Park , IL 60064 |
Implementation of additional in-process testing. |
| P060007/S001 10/18/06 |
Architect HBsAg and HBsAg Confirmatory | Abbott Laboratories Diagnostics Division Abbott Park , IL 60064 |
Addition of specifications, the modification of specifications, and additional testing during the manufacturing process. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 46
Summary of PMA Originals Under Review
Total Under Review: 83
Total Active: 32
Total On Hold: 51
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 447
Total Active: 238
Total On Hold: 209
Number Greater Than 180 Days: 13
Summary of All PMA Submissions Received
Originals: 5
Supplements: 123
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 46
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 91.7
FDA Time: 57.7 Days MFR Time: 34.0 Days
Updated February 29, 2008
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