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
| P060038 10/23/07 |
Mitroflow Aortic Pericardial Heart Valve | CarboMedics, Inc. Austin , TX 78752 |
Approval for the Mitroflow Aortic Pericardial Heart Valve, sizes 19, 21, 23, 25, and 27 mm. The device is intended for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. |
| P070012 10/23/07 |
Exponent® Self-Expanding Carotid Stent System with Over-the-Wire or Rapid-Exchange Delivery System | Medtronic Vascular Santa Rosa , CA 95403 |
Approval for the Exponent® Self-Expanding Carotid Stent System with Over-the-Wire or Rapid-Exchange Delivery System. The device is indicated for use, in conjunction with a Medtronic Vascular Embolic protection system, for improving carotid luminal diameter in 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 either ultrasound or angiogram, or patients without neurological symptoms and ≥80% stenosis of the common or internal carotid artery by either ultrasound or angiogram; and 2) Patients having a vessel with reference diameters between 4.5 mm and 9.5 mm at the target lesion. |
PMA Supplemental Approvals
| P840024/S087 10/16/07 Real-Time |
Nucleus 22 Cochlear Implant System | Cochlear Americas Englewood , CO 80112 |
Approval for modifications to Custom sound programming software to provide receipts of previous generation Nucleus 22 cochlear implants with access to the Nucleus Freedom Speech Processor. |
| P840062/S014 10/30/07 180-Day |
HeliTape and HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery | Integra LifeSciences Corporation Plainsboro , NJ 08536 |
Approval for the addition of two new trade names - HeliTape and HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery. |
| P880086/S149 10/29/07 135-Day |
Identity, Verity, Integrity, Victory, and Zephyr Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for a modification to the cleaning process used for the hybrids of pacemaker devices. |
| P890003/S123 10/16/07 Real-Time |
Medtronic Carelink Monitor Programmer Model 2090 | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview , MN 55126 |
Approval for Software Model SW0007. |
| P890003/S125 10/4/07 Real-Time |
Carelink Programmer | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview , MN 55126 |
Approval for software and RAM-ware maintenance updates as well as associated reference and implant manual updates. |
| P890027/S056 10/16/07 Real-Time |
Nucleus 22 Cochlear Implant System | Cochlear Americas Englewood , CO 80112 |
Approval for modifications to Custom sound programming software to provide receipts of previous generation Nucleus 22 cochlear implants with access to the Nucleus Freedom Speech Processor. |
| P900056/S090 10/3/07 Real-Time |
Rotablator™ Rotational Angioplasty System | Boston Scientific Corp. Maple Grove , MN 55311 |
Approval for revisions to the Directions for Use for the Rotablator™ Rotational Angioplasty System, Guidewire with wireClip Torquer. |
| P910023/S151 10/5/07 Real-Time |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for several software changes for version 7.0.74 for the firmware and for version 6.3.1 for the Model 3330 Software for the Model 3650 Merlin™ Patient Care System. |
| P910077/S078 10/18/07 Real-Time |
ZOOM Latitude Programming System Model 3120 | Guidant Corp. St. Paul , MN 55112 |
Approval for leakage current re-classification from CF to BF as well as associated labeling and operator manual updates. |
| P940019/S021 10/5/07 Special |
Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for changes to the Directions for Use. |
| P950022/S041 10/16/07 Real-Time |
Riata ST Optim™ Leads and Riata STS Optim™ Leads |
St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval to modify the shock coil on the Riata ST Optim™ and Riata STS Optim™ leads and to add two new passive lead models. The devices, as modified, will be marketed under the trade name Riata ST Optim™ Lead Models 7020, 7021, 7022, 7030, 7031, 7070 and 7071 and Riata STS Optim™ Lead Models 7120, 7121,7122, 7130, 7131, 7170 and 7171 and are indicated for use with compatible pulse generators (refer to the applicable defibrillator manul for system indications). They provide pacing and sensing and deliver cardioversion/ defibrillation therapy to the heart. |
| P960009/S042 10/17/07 Special |
Activa® Therapy for Deep Brain Stimulation | Medtronic Neurological Minneapolis , MN 55432 |
Approval for te addition of a precaution to patient manuals of the Model 7436 and Model 7438 Therapy Controllers. |
| P960040/S146 10/18/07 Real-Time |
PRIZM, VITALITY and CONTAK RENEWAL Families of Devices | Guidant Corporation St. Paul, MN 55112 |
Approval for minor labeling changes for the PRIZM, VITALITY and CONTAK RENEWAL families of devices. |
| P970003/S085 10/23/07 180-Day |
VNS Therapy™ System | Cyberonics, Inc. Houston , TX 77058 |
Approval for the post-approval study. |
| P970003/S089 10/11/07 Special |
VNS Therapy™ System | Cyberonics, Inc. Houston , TX 77058 |
Approval for the addition of instructions to the troubleshooting section in the Model 250 Programming Software Physician’s Manual v.7.1 and minor corresponding changes to the Handheld Computer Connection Instructions (HP Jornada, Dell Axim X5 and X50). |
| D970003/S090 10/16/07 Real-Time |
Insignia Family Programmer Software Model 2892 | Guidant Corporation St. Paul , MN 55112 |
Approval for software version v1.28 and v3.11 for Programmer Software Model 2892. |
| P970004/S040 10/23/07 180-Day |
Medtronic Interstim Tined Lead Models 3889 & 3093 | Medtronic Neurological Minneapolis , MN 55432 |
Approval of the post-approval study. |
| P970004/S043 10/15/07 Special |
InterStim® Therapy for Urinary Control | Medtronic Neurological Minneapolis , MN 55432 |
Approval for the addition of a precaution and other minor modifications of the device labeling. |
| P970054/S005 10/10/07 135-Day |
Parvovirus B19 IgG Enzyme Immunoassay | Biotrin Technologies LTD Dublin , Ireland |
Approval for the reduction in plate wash volume. |
| P970055/S005 10/10/07 135-Day |
Parvovirus B19 IgM Enzyme Immunoassay | Biotrin Technologies LTD Dublin , Ireland |
Approval for the reduction in plate wash volume. |
| P980003/S020 10/29/07 Special |
Model 8005 Pump System (CircuCool Pump), Model M00480050 |
Boston Scientific Corp. San Jose , CA 95134 |
Approval for incorporation of a warning and EMC statement to the Model 8005 Pump System (CircuCool Pump) Operator’s Manual. |
| P980040/S015 10/30/07 180-Day |
SENSAR® One-Piece Acrylic Posterior Chamber Intraocular Lens (Model AAB00) and TECNIS™ One-Piece Acrylic Posterior Chamber Intraocular Lens (Model ZCB00) | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Approval for two new models of SENSAR® Soft Acrylic UV Light-absorbing Posterior Chamber Intraocular Lenses (IOLs) and the claims for reduced postoperative spherical aberrations and improved night-driving simulator performance. The new models are SENSAR® One-Piece Acrylic Posterior Chamber Intraocular Lens (Model AAB00) and TECNIS™ One-Piece Acrylic Posterior Chamber Intraocular Lens (Model ZCB00). The two models differ from the parent models as follows: single piece design, the addition of a surface treatment to the acrylic material, and slight reduction in the center thickness with zero angulation. |
| P980049/S027 10/23/07 180-Day |
Ovatio DR Model 6550 and Ovatio VR Model 6260 |
Ela Medical Plymouth , MN 55441 |
Approval of the post-approval study. |
| P990040/S005 10/15/07 135-Day |
TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System |
Cordis Neurovascular, Inc. Miami Lakes , FL 33014 |
Approval for a change in the cleaning process and inspection of product containers. |
| P000029/S032 10/30/07 135-Day |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Approval for the removal of two of the visual inspection steps in the production process. |
| P000039/S022 10/5/07 135-Day |
AMPLATZER® Septal Occluder and AMPLATZER® MultiFenestrated Septal Occluder – “Cribriform” | AGA Medical Corp. Plymouth , MN 55442 |
Approval for the modification of the device load test from a manual to a partially automated procedure. |
| P000054/S011 10/5/07 135-Day |
INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis , TN 38132 |
Approval for the Alternate 2X Manufacturing Process of rhBMP-2. |
| P000058/S023 10/5/07 135-Day |
INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis , TN 38132 |
Approval for the Alternate 2X Manufacturing Process of rhBMP-2. |
| P010003/S011 10/18/07 Real-Time |
BioGlue Surgical Adhesive | CryoLife, Inc. Kennesaw , GA 30144 |
Approval for a change to the sterile 5 ml syringe product. |
| P010012/S153 10/18/07 Real-Time |
PRIZM, VITALITY and CONTAK RENEWAL Families of Devices | Guidant Corporation St. Paul, MN 55112 |
Approval for minor labeling changes for the PRIZM, VITALITY and CONTAK RENEWAL families of devices. |
| P010030/S008 10/31/07 Real-Time |
LifeVest WCD 3000 | Zoll Lifecor Corporation Pittsburgh , PA 15238 |
Approval for a change in the battery pack PCA artwork, addition of 100-ohm resistor at U3 pin 1, and a change of the double-sided pressure sensitive adhesive (PSA) tape. |
| P010031/S076 10/4/07 Real-Time |
InSync Sentry, Maximo CRT-D’s | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview , MN 55126 |
Approval for software and RAM-ware maintenance updates as well as associated reference and implant manual updates. |
| P010033/S011 10/10/07 180-Day |
QuantiFERON® - TB GOLD In-Tube | Cellestis, Inc. Valencia , CA 91355 |
Approval for a modification of the QuantiFERON® - TB GOLD to an in-tube collection system that consists of three blood collection tubes, Nil, TB antigen, and mitogen. The device, as modified, will be marketed under the trade name QuantiFERON® - TB GOLD In-Tube and is indicated for use as an in vitro diagnostic test using a peptide cocktail simulating ESAT-6, CFP-10 and TB 7.7(p4) proteins to stimulate cells in heparinized whole blood drawn directly into specialized blood collection tubes. Detection of interferon-γ by Enzyme-Linked Immunosorbent Assay (ELISA) is used to identify in vitro responses to these peptide antigens that are associated with Mycobacterium tuberculosis infection. |
| P020003/S005 10/9/07 180-Day |
Coloplast Saline-Filled Testicular Implant | Coloplast Corp. Minneapolis , MN 55411 |
Approval for labeling changes to report post approval study results. |
| P020024/S016 10/5/07 135-Day |
AMPLATZER® Duct Occluder | AGA Medical Corp. Plymouth , MN 55442 |
Approval for the modification of the device load test from a manual to a partially automated procedure. |
| P020026/S039 10/26/07 135-Day |
CYPHER® Sirolimus-eluting Coronary Stent | Cordis Corporation Miami Lakes , FL 33014 |
Approval for a change in the sampling plan for balloon attribute functional tests conducted at the Crimp and Pack unit operation. |
| P020026/S042 10/16/07 180-Day |
CYPHER™ Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System (CYPHER Stent) | Cordis Corporation Miami Lakes , FL 33014 |
Approval for revisions to the Instructions for Use. |
| P020047/S010 10/26/007 180-Day |
Multi-Link Vision® Coronary Stent System and Multi-Link Mini Vision® Coronary Stent System | Abbott Vascular Temecula , CA 92591 |
Approval for a manufacturing site located at Abbott Vascular, Galway, Ireland. |
| P030004/S003 10/9/07 Special |
Onyx Liquid Embolic System | ev3 Neurovascular Irvine , CA 92618 |
Approval for revision of the product label to include a boxed Warning regarding the emission of sparks that occurs when Onyx-embolized tissue is surgically resected with monopolar electrocautery devices. |
| P030017/S025 10/30/07 180-Day |
PRECISION Connector-M1 | Advanced Bionics Sylmar , CA 91342 |
Approval for the Precision OMG (Observational Mechanical Gateway) Connector-M1, Models SC-9004-35, SC-9004-55, and SC-9004-70. |
| P030019/S009 10/26/07 180-Day |
Orthovisc® Sodium Hyaluronate | Anika Therapeutics, Inc. Woburn , MA 01801 |
Approval for modifying the manufacturing process for Orthovisc® to one that produces sodium hyaluronate from bacterial fermentation. The device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen). |
| P030022/S006 10/12/07 135-Day |
Reflection Ceramic Acetabular Hip System | Smith & Nephew, Inc. Memphis , TN 38116 |
Approval for the elimination of sterilization cycle 204, a reduction in the required number of process challenge devices (PCD), the increase in the length of PCD tubing, a reduction in the number of PCDs that need to be tested when some of the PCDs are damaged or lost, and a change in the placement pattern for biological indicators. |
| P030025/S047 10/16/07 180-Day |
TAXUS™ Express 2™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for revisions to the Instructions for Use. |
| P030035/S033 10/29/07 135-Day |
Frontier and Frontier II CRT-P Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for a modification to the cleaning process used for the hybrids of pacemaker devices. |
| P030054/S064 10/5/07 Real-Time |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for several software changes for version 7.0.74 for the firmware and for version 6.3.1 for the Model 3330 Software for the Model 3650 Merlin™ Patient Care System. |
| P040001/S007 10/4/07 180-Day |
X-STOP® Interspinous Process Decompression® System | Kyphon, Inc. Sunnyvale , CA 94089 |
Approval for a modified version of the tissue expander of the titanium version of the X-STOP Spacer Assembly. |
| P040013/S011 10/1/07 135-Day |
GEM 21S® Growth Factor Enhanced Matrix | Biomimetic Therapeutics, Inc. Franklin , TN 37067 |
Approval for a scale up of the manufacturing of the drug component for the GEM 21® combination product. |
| P040020/S005 10/24/07 Real-Time |
Acrysof® ReSTOR Apodized Diffractive Optic Posterior Chamber Intraocular Lens (IOL), Models SA60D3, SN60D3, MA60D3 and MN60D3 | Alcon Research, Ltd. Fort Worth , TX 76134 |
Approval for expansion of the dioptric range of the referenced models from 10.0D to 30.0D to 6.0D to 30.0D. The device models, as modified, will be marketed under the trade name Acrysof® ReSTOR Apodized Diffractive Optic Posterior Chamber Intraocular Lens (IOL), Models SA60D3, SN60D3, MA60D3 and MN60D3, and are indicated for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. These lenses are intended for placement in the capsular bag. |
| P040033/S004 10/1/07 180-Day |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew, Inc. Memphis , TN 38116 |
Approval of the post-approval study. |
| P040050/S002 10/3/07 180-Day |
Macroplastique® Implants | Uroplasty, Inc. Minnetonka , MN 55343 |
Approval for a manufacturing site located at Uroplasty, Inc., Minnetonka, Minnesota. |
| P050012/S012 10/22/07 180-Day |
DexCom™ Seven™ System |
DexCom, Inc. San Diego , CA 92121 |
Approval for a manufacturing site located at DexCom, Inc., San Diego, California. |
| P050016/S001 10/18/07 180-Day |
Cormet Hip Resurfacing System | Corin USA Tampa , FL 33612 |
Approval of the post-approval study. |
| P050018/S003 10/18/07 180-Day |
AngioSculpt PTCA Scoring Balloon Catheter | AngioScore, Inc. Fremont , CA 94538 |
Approval for a manufacturing site located at AngioScore, Inc., Fremont, California. |
| P050033/S005 10/3/07 180-Day |
Elevess | Anika Therapeutics, Inc. Woburn , MA 01801 |
Approval for the change in product trade name. the device, as modified, will be marketed under the trade name Elevess and is indicated for injection into the mid to deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). |
| P050053/S002 10/5/07 135-Day |
INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis , TN 38132 |
Approval for the Alternate 2X Manufacturing Process of rhBMP-2. |
| P060017/S001 10/23/07 180-Day |
GeneSearch Breast Lymph Node Assay | Veridex Warren , NJ 07059 |
Approval for the post-approval study. |
30-Day Notices (135 Day Supplement was not required)
| P790007/S020 10/18/07 |
HANCOCK® Modified Orifice (MO) Valved Conduit | Medtronic Heart Valves Santa Ana , CA 92705 |
Additional suppliers for porcine aortic heart valves. |
| P810006/S029 10/3/07 |
CollaStat Absorbable Collagen Hemostatic Agents | Integra Life Sciences Plainsboro , NJ 08536 |
Upgrade of production processing equipment and changing a manual process to an automated process. |
| P830045/S110 10/24/07 |
Various Families of Pacemakers and 3510 Programmer | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Reduction in the frequency of monitoring for various water system tests. |
| P840062/S015 10/3/07 |
CollaCote Absorbable Collagen Hemostatic Agents | Integra Life Sciences Plainsboro , NJ 08536 |
Upgrade of production processing equipment and changing a manual process to an automated process. |
| P850010/S026 10/3/07 |
Helistat Absorbable Collagen Hemostatic Agents | Integra Life Sciences Plainsboro , NJ 08536 |
Upgrade of production processing equipment and changing a manual process to an automated process. |
| P880081/S034 10/24/07 |
Silicone Intraocular Lens | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Increase in the frequency of microbiological monitoring for the water system in the Advanced Medical Optics (AMO) Añasco, Puerto Rico Facility. |
| P880086/S152 10/24/07 |
Passive Plus DX Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Reduction in the frequency of monitoring for various water system tests. |
| P880086/S153 10/26/07 |
Identity, Integrity, Verity, Victory, and Zephyr Implantable Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Alternate supplier of XL size cans. |
| P880086/S154 10/31/07 |
Passive Fixation Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change in the manufacturing environment from a Class 10,000 clean room to a Class 100,000 clean room for the assembly of the low-voltage and left ventricular families of leads. |
| P910023/S155 10/12/07 |
Cadence ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Alternate supplier for the Isolation Transformer Module (ITM) used on the high voltage assembly of the Current™ ICDs and Promote™ CRT-Ds. |
| P910023/S156 10/19/07 |
Cadence Family of Devices | St. Jude Medical Sylmar , CA 91342 |
Minor changes to the automated test software. |
| P910023/S158 10/24/07 |
Various Families of Implantable Cardioverter Defibrillators (ICDs) and Merlin Programmer | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Reduction in the frequency of monitoring for various water system tests. |
| P910077/S079 10/19/07 |
Various Pacemakers and ICDs | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Modifications to the test software for the Model 3120 ZOOM LATITUDE Programmer. |
| P950005/S023 10/29/07 |
Celsius and EZ Steer Family of Catheters | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Change to the ethylene oxide sterilization cycle process parameters. |
| P950022/S043 10/19/07 |
Riata Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Alternate supplier for ETFE coated cables. |
| P960013/S034 10/31/07 |
Active Fixation Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change in the manufacturing environment from a Class 10,000 clean room to a Class 100,000 clean room for the assembly of the low-voltage and left ventricular families of leads. |
| P960028/S024 10/24/07 |
Array Multifocal Intraocular Lens and ReZoom Multifocal Intraocular Lens | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Increase in the frequency of microbiological monitoring for the water system in the Advanced Medical Optics (AMO) Añasco, Puerto Rico Facility. |
| P960030/S017 10/24/07 |
Various Families of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Reduction in the frequency of monitoring for various water system tests. |
| P960030/S018 10/31/07 |
Cardiovascular Permanent Pacemaker Electrode | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change in the manufacturing environment from a Class 10,000 clean room to a Class 100,000 clean room for the assembly of the low-voltage and left ventricular families of leads. |
| P960040/S153 10/29/07 |
PRIZM 2 ICDs and VITALITY ICDs | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Addition of a second source supplier of thin film resistors. |
| D970003/S093 10/26/07 |
INSIGNIA and NEXUS | Guidant Corporation St. Paul , MN 55112 |
Addition of a second in-line medical adhesive cure oven. |
| D970012/S045 10/24/07 |
AMS 700 Series Inflatable Penile Prosthesis | American Medical Systems Minnetonka , MN 55343 |
Change in the sampling plan for incoming inspection of tubing connectors in the accessory kit. |
| P970020/S049 10/24/07 |
MULTI-LINK ZETA® RX Coronary Stent System | Abbott Vascular, Inc. Temecula , CA 92591 |
Replacing bonding equipment with a new heat bonder at three bonding processes of the proximal and distal shaft subassembly. |
| P970020/S050 10/29/07 |
Multi-Link Vision RX Zeta® Coronary Stent System | Abbott Vascular, Inc. Temecula , CA 92591 |
Change in e-beam irradiation equipment. |
| P970031/S020 10/18/07 |
FREESTYLE® Aortic Root Bioprosthesis | Medtronic Heart Valves Santa Ana , CA 92705 |
Additional suppliers for porcine aortic heart valves. |
| P980040/S018 10/24/07 |
Sensar Acrylic Intraocular Lens | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Increase in the frequency of microbiological monitoring for the water system in the Advanced Medical Optics (AMO) Añasco, Puerto Rico Facility. |
| P980043/S013 10/18/07 |
HANCOCK® Modified Orifice (MO) Valved Conduit | Medtronic Heart Valves Santa Ana , CA 92705 |
Additional suppliers for porcine aortic heart valves. |
| P990020/S027 10/26/07 |
AneuRx AAAdvantage Stone Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rosa , CA 95403 |
Use (by the current supplier of bifurcated graft components) of an alternate supplier of polyester yarn for the manufacture of all AneuRx AAAdvantage bifurcated and iliac limb subcomponent configurations. |
| P990025/S014 10/29/07 |
Quikstar Family of Catheters | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Change to the ethylene oxide sterilization cycle process parameters. |
| P990064/S020 10/18/07 |
MOSAIC® Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana , CA 92705 |
Additional suppliers for porcine aortic heart valves. |
| P990080/S027 10/24/07 |
Tecnis Acrylic Intraocular Lens | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Increase in the frequency of microbiological monitoring for the water system in the Advanced Medical Optics (AMO) Añasco, Puerto Rico Facility. |
| P000025/S028 10/24/07 |
COMBI 40+ Cochlear Implant System | MED-EL Corporation Durham , NC 27713 |
Addition of a cleanroom module. |
| P000053/S011 10/24/07 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka , MN 55343 |
Change in the sampling plan for incoming inspection of tubing connectors in the accessory kit. |
| P010012/S162 10/29/07 |
CONTAK RENEWAL CRT-Ds | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Addition of a second source supplier of thin film resistors. |
| P010020/S007 10/24/07 |
Acticon Artificial Bowel Sphincter | American Medical Systems Minnetonka , MN 55343 |
Change in the sampling plan for incoming inspection of tubing connectors in the accessory kit. |
| P010068/S011 10/29/07 |
Navistar and EZ Steer Family of Catheters | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Change to the ethylene oxide sterilization cycle process parameters. |
| P020004/S029 10/19/07 |
Gore EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates Inc. Flagstaff , AZ 86001 |
Alternate site for performing the verification of the graft attach process. |
| P020047/S011 10/29/07 |
Multi-Link Vision® RX Coronary Stent System | Abbott Vascular, Inc. Temecula , CA 92591 |
Change in e-beam irradiation equipment. |
| P030005/S047 10/26/07 |
CONTAK RENEWAL TR | Guidant Corporation St. Paul , MN 55112 |
Addition of a second in-line medical adhesive cure oven. |
| P030006/S016 10/24/07 |
Prolieve Thermodilitation System | Boston Scientific Corporation Marlborough , MA 01752 |
Changes intended to reduce in-process scrap of the catheter component. |
| P030031/S007 10/29/07 |
Navistar and Celsius Family of Catheters | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Change to the ethylene oxide sterilization cycle process parameters. |
| P030035/S035 10/31/07 |
Left Ventricular Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change in the manufacturing environment from a Class 10,000 clean room to a Class 100,000 clean room for the assembly of the low-voltage and left ventricular families of leads. |
| P030054/S068 10/12/07 |
Epic HR CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Alternate supplier for the Isolation Transformer Module (ITM) used on the high voltage assembly of the Current™ ICDs and Promote™ CRT-Ds. |
| P030054/S069 10/19/07 |
Epic HF/Atlas + HF Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) | St. Jude Medical Sylmar , CA 91342 |
Minor changes to the automated test software. |
| P030054/S071 10/31/07 |
Left Ventricular Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change in the manufacturing environment from a Class 10,000 clean room to a Class 100,000 clean room for the assembly of the low-voltage and left ventricular families of leads. |
| P040024/S013 10/12/07 |
Restylane® Injectable Gel | Medicis Aesthetics Holding, Inc. Scottsdale , AZ 85258 |
Change to the method for counting syringes during the assembly process from manual to an automated process. |
| P040036/S004 10/29/07 |
Navistar Family of Catheters | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Change to the ethylene oxide sterilization cycle process parameters. |
| P040042/S011 10/19/07 |
Safire™ TX Catheter | Irvine Biomedical, Inc. Irvine , CA 92614 |
Rerouting of one set of thermocouple wires and a modification to the activation wire. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 55
Summary of PMA Originals Under Review
Total Under Review: 72
Total Active: 32
Total On Hold: 40
Number Greater Than 180 Days: 2
Summary of PMA Supplements Under Review
Total Under Review: 439
Total Active: 278
Total On Hold: 161
Number Greater Than 180 Days: 10
Summary of All PMA Submissions Received
Originals: 2
Supplements: 132
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 55
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 120.7
FDA Time: 92.4 Days MFR Time: 28.3 Days
Updated February 4, 2008
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