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.
| P040025 12/20/06 |
Olympic Cool-Cap® | Olympic Medical Seattle, WA 98108 |
Approval for the Olympic Cool-Cap®. The Olympic Cool-Cap® is indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE). Cool-Cap provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. |
| P050033 12/20/06 |
Cosmetic Tissue Augmentation Product | Anika Therapeutics, Inc. Woburn, MA 01801 |
Approval for the Cosmetic Tissue Augmentation Product. This device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). |
| P050037 12/22/06 |
Radiesse 1.3cc and 0.3cc | BioForm Medical, Inc. San Mateo, CA 94402 |
Approval for Radiesse. This device is indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. |
| P050052 12/22/06 |
Radiesse 1.3cc and 0.3cc | BioForm Medical, Inc. San Mateo, CA 94402 |
Approval for Radiesse. This device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. |
| P060010 12/14/06 |
The Spanner™ Temporary Prostatic Stent | AbbeyMoor Medical, Inc. Parkers Prairie, MN 56361 |
Approval for the Spanner™ Temporary Prostatic Stent. The device is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for benign prostatic hyperplasia (BPH) and after initial post-treatment catheterization. |
| P800022/S055 12/19/06 180-Day |
CosmoDerm™/ CosmoPlast™ Collagen Implant, CosmoDerm® CosmoPlast® Human-Based Collagen Implant | Allergan Santa Barbara, CA 93111 |
Approval for a change in the glutaraldehyde crosslinker concentration. |
| P810002/S061 12/20/06 Real-Time |
St. Jude Medical® Mechanical Heart Valve | St. Jude Medical, Inc, St. Paul, MN 55117 |
Approval for changes to the Educational booklet for all patients receiving a St. Jude Medical® Mechanical Heart Valve. |
| P810046/S220 12/11/06 180-Day |
Coronary Dilatation Catheters | Abbott Vascular, Inc. Temecula, CA 92591 |
Approval for an alternate sterilization site located at Sterigenics, Santa Teresa, New Mexico. |
| P810046/S221 12/11/06 180-Day |
Coronary Dilatation Catheters | Abbott Vascular, Inc. Temecula, CA 92591 |
Approval for an alternate sterilization site located at Isotron Ireland, LTD, Offaly, Ireland. |
| P860003/S045 12/22/06 Real-Time |
Therakos UVAR® XTS Photopheresis System | Therakos Exton, PA 19341 |
Approval for a material change for the spike portion of the drip chamber of the UVAR® XTS Procedural Kit, which is used with the UVAR® XTS Photopheresis System. |
| P860047/S019 12/21/06 180-Day |
Ocucoat® (2% Hydroxypropyl-methylcellulose Solution) | Bausch and Lomb San Dimas, CA 91773 |
Approval for a manufacturing site located at 8500 Hidden River Parkway, Tampa, Florida. |
| P880086/S126 12/21/06 Real-Time |
Affinity/Identity/ADX Families of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division | Approval for alternative tantalum capacitors. |
| P890043/S039 12/11/06 180-Day |
Coronary Atherectomy Catheters | Abbott Vascular, Inc. Temecula, CA 92591 |
Approval for an alternate sterilization site located at Sterigenics, Santa Teresa, New Mexico. |
| P910023/S126 12/13/06 Real-Time |
St. Jude Medical™ Epic II/Epic II + and Atlas II/Atlas II + ICDs and CRT-D Systems | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for the following modifications to the ICD/CRT-D device hybrid: 1) addition of a new C64 micro controller integrated circuit (IC); 2) changes to the C46 VSS supply capacitor from 3.3 uF to 33 uF; and 3) changes to diodes D17, D19 and D23 in the protection circuit. |
| P910023/S127 12/14/06 Real-Time |
St. Jude Medical Housecall Plus™ System | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for the St. Jude Medical Housecall Plus™ System which will allow Interactive Voice Response (IVR). |
| P910023/S128 12/14/06 Real-Time |
St. Jude Medical™ Epic DR/VR/HF, Epic+ DR/VR, Epic II/II+ DR/VR/HR, Atlas, Atlas+, and Atlas II/II+ ICD Systems |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for: 1) A n alternate electrolyte (TM422) in the high voltage capacitor used in the St. Jude Medical Epic DR/VR/HF, Epic+ DR/VR and Epic II/II + DR/VR/HF devices; and 2) The minor modifications to the crystal tuning fork used in Epic, Epic+, Epic II/II +, Atlas, Atlas+, Atlas II/II + devices. |
| P910061/S015 12/6/06 Real-Time |
Model LI61AO Intraocular Lens | Bausch & Lomb San Dimas, CA 91773 |
Approval to add a statement to the Directions for Use that the SofPort Model LI61 AO IOL has prolate aspheric surfaces and is designed to be free of spherical aberrations, and to add a figure with the modulation transfer functions for the LI61AO and LI61SE lenses. |
| P920047/S035 12/1/06 Real-Time |
Boston Scientific XP APM™ (Automatic Personality Module) Unit, Model 822T | Boston Scientific Corporation San Jose, CA 95134 |
Approval for the addition of a choke in the XP APM™ which will eliminate the delivery of the RF energy where the user failed to connect or improperly connected the Dispersive Indifferent Patch (DIP) electrodes to the patient. |
| P920047/S036 12/21/06 Real-Time |
Blazer II Cardiac Ablation Catheter and SteeroCath-T Cardiac Ablation Catheter | Boston Scientific Corporation San Jose, CA 95134 |
Approval for modification of the steering mechanism for the N4 curve version of the Blazer II Cardiac Ablation Catheter and SteeroCath-T Cardiac Ablation Catheter and the use of a new soldering fixture in the manufacturing process. |
| P950022/S032 12/14/06 Real-Time |
Riata Lead Models 1580, 1581 and 1582; Riata, Riata ST and Riata ST Optim Lead Families | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a helix attachment modification for the Riata 1580, 1581 and 1582 leads as well as a crimp-weld coupling modification for the Riata, Riata ST and Riata ST Optim lead families. |
| P950037/S046 12/7/06 180-Day |
Lumax Implantable Cardioverter Defibrillators (ICDs): Models 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T and 340 HF-T and CardioMessenger II and Programmer Software Version 603.U for use with Lumax family of ICDs, Biotronik, Inc. pacers, single chamber ICDs and dual chamber ICDs | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Lumax Implantable Cardioverter Defibrillators (ICDs), Models 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T and 340 HF-T and Programmer Software Version 603.U for use with the Lumax family of ICDs and Biotronik, Inc. pacers, single chamber ICDs and dual chamber ICDs. The device, as modified, will be marketed under the trade name Lumax, and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and/or for providing treatment of congestive heart failure. |
| P960011/S012 12/19/06 180-Day |
BD 1% OVD | Ferring Pharmaceuticals, Inc. Suffern, NY 10901 |
Approval to change the trade name from Biolon to BD1% OVD. |
| P960013/S023 12/5/06 Real-Time |
Tendril SDX Lead Models 1488T and 1488TC | St. Jude Medical Sylmar, CA 91342 |
Approval for a new 3-groove suture sleeve design for the Tendril SDX Lead Models 1488T and 1488TC. |
| P980016/S091 12/14/06 Real-Time |
EnRhythm Implantable Pulse Generator and EnTrust Implantable Cardioverter Defibrillators | Medtronic, Inc. Shoreview, MN 55126 |
Approval for design changes to the MO16 SRAM packaging for the device hybrids and a change in the barometric pressure requirement from 6 ATA to 4 ATA for the EnRhythm Implantable Pulse Generator and EnTrust Implantable Cardioverter Defibrillators. |
| P980022/S014 12/27/06 180-Day |
Guardian RT | Medtronic MiniMed Corporation Northridge, CA 91325 |
Approval of the post-approval study. |
| P980023/S025 12/7/06 180-Day |
Lumax Implantable Cardioverter Defibrillators (ICDs): Models 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T and 340 HF-T and CardioMessenger II and Programmer Software Version 603.U for use with Lumax family of ICDs, Biotronik, Inc. pacers, single chamber ICDs and dual chamber ICDs | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Lumax Implantable Cardioverter Defibrillators (ICDs), Models 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T and 340 HF-T and Programmer Software Version 603.U for use with the Lumax family of ICDs and Biotronik, Inc. pacers, single chamber ICDs and dual chamber ICDs. The device, as modified, will be marketed under the trade name Lumax, and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and/or for providing treatment of congestive heart failure. |
| P980035/S068 12/14/06 Real-Time |
EnRhythm Implantable Pulse Generator and EnTrust Implantable Cardioverter Defibrillators | Medtronic, Inc. Shoreview, MN 55126 |
Approval for design changes to the MO16 SRAM packaging for the device hybrids and a change in the barometric pressure requirement from 6 ATA to 4 ATA for the EnRhythm Implantable Pulse Generator and EnTrust Implantable Cardioverter Defibrillators. |
| P980037/S014 12/7/06 180-Day |
AngioJet™ Ultra Thrombectomy System | Possis Medical, Inc. Minneapolis, MN 55433 |
Approval for a redesign of the drive unit (Ultra Console) and to combine the pump set and catheters into a single Thrombectomy Set (with different models corresponding to the current XMI and XMI-RX catheter models). |
| P990009/S018 12/1/06 180-Day |
FloSeal Hemostatic Matrix | Baxter Healthcare Corporation Hayward, CA 94545 |
Approval for a manufacturing site located in Hayward, California. |
| P990037/S024 12/22/06 Panel |
Vascular Solutions D-Stat Flowable Hemostat | Vascular Solutions, Inc. Minneapolis, MN 55369 |
Approval for a new indication for use for the D-Stat Flowable Hemostat. The device is indicated for use in high-risk anti-coagulated patients undergoing implantation of a pulse generator (e.g., pacemaker or ICD) to reduce the frequency of clinically relevant hematoma formation in the prepectoral pocket. D-Stat Flowable is indicated for use in high-risk anti-coagulated patients undergoing implantation of a pulse generator (e.g., pacemaker or ICD to reduce the frequency of clinically relevant hematoma formation in the prepectoral pocket. High-risk patients are defined as those whose anti-coagulation regimens will resume within 24 hours of implant. Clinically relevant hematomas are defined as those that result in an alteration in the standard of care resultant of hematoma formation including alteration (i.e. suspension or discontinuation) of the anticoagulant therapy regimen (Heparin, LMWH, Warfarin, or Clopidogrel), application of a compression bandage and evacuation of the hematoma. |
| P990052/S015 12/13/06 Real-Time |
Vibrant MED-EL | Vibrant Med-EL Hearing Technology Innsbruck, Austria |
Approval for a change in the wording of the indications for use statement and a new product code description that removes the reference to hearing aids. The device is indicated for use in adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids. |
| P000009/S020 12/7/06 180-Day |
Lumax Implantable Cardioverter Defibrillators (ICDs): Models 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T and 340 HF-T and CardioMessenger II and Programmer Software Version 603.U for use with Lumax family of ICDs, Biotronik, Inc. pacers, single chamber ICDs and dual chamber ICDs |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Lumax Implantable Cardioverter Defibrillators (ICDs), Models 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T and 340 HF-T and Programmer Software Version 603.U for use with the Lumax family of ICDs and Biotronik, Inc. pacers, single chamber ICDs and dual chamber ICDs. The device, as modified, will be marketed under the trade name Lumax, and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and/or for providing treatment of congestive heart failure. |
| P000043/S015 12/15/06 180-Day |
TMx-2000™ TherMatrx Office Thermo Therapy System | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for changes to the labeling to incorporate the results of the 5-year postapproval study. The device, as modified, will be marketed under the trade name TMx-2000™ TherMatrx Office Thermo Therapy System and is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men who have a minimum prostatic urethra length of 25 mm and a total prostate volume between 30 and 100 cc. |
| P010020/S002 12/21/06 180-Day |
AMS Acticon® Neosphincter | American Medical Systems Minnetonka, MN 55343 |
Approval for labeling changes. |
| P020009/S029 12/11/06 135-Day |
Express 2 Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a heat shrink change for the proximal and midshaft welds. |
| P020025/S018 12/21/06 Real-Time |
Blazer II XP Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Approval for modification of the steering mechanism for the N4 curve version of the Blazer II XP catheters and the use of a new soldering fixture in the manufacturing process. |
| P020026/S031 12/7/06 Special |
CYPHER™ Sirolimus-Eluting Coronary stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System (CYPHER Stent) | Cordis Corporation Miami, FL 33102 |
Approval for an updated analytical test method for water content determination. |
| P020026/S032 12/7/06 Special |
CYPHER™ Sirolimus-Eluting Coronary stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System (CYPHER Stent) | Cordis Corporation Miami, FL 33102 |
Approval for an updated analytical test method for solvent residue after evaporation. |
| P030006/S012 12/22/06 Real-Time |
Celsion Prolieve™ Thermodilatation System | Celsion Corporation Columbia, MD 21046 |
Approval for removal of a capacitor from the computer board input lines to enable the tachometer readout to display pump speed and modification of the capacitors from the computer input/output board to display of temperature data. |
| P030009/S008 12/8/06 Special |
Medtronic Vascular Driver MX 2 Coronary Stent System & MicroDriver MX 2 Coronary Stent System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Approval for the addition of a warning, which will inform the physician of the potential vessel wall damage that could occur if fluoroscopy is not used during wire interchange, and an update of the guide wire interchange instructions to ensure that physicians use high quality fluoroscopy to determine guide wire position before advancing into the coronary arteries. |
| P030017/S013 12/21/06 180-Day |
Precision™ Spinal Cord Stimulation (SCS) System | Advanced Bionics Sylmar, CA 91342 |
Approval to add an alternate sterilization cycle. |
| P030025/S033 12/21/06 135-Day |
TAXUS™ Express 2™ Paclitaxel-Eluting CSS |
Boston Scientific Corporation Cardiovascular Division Maple Grove, MN 55311 |
Approval for an additional sterilization chamber at a contract sterilization facility. |
| P030025/S035 12/11/06 135-Day |
TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a heat shrink change for the proximal and midshaft welds. |
| P030025/S041 12/20/06 Real-Time |
TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for an extension of shelf life from 12 to 18 months. |
| P030035/S019 12/21/06 Real-Time |
Affinity/Identity/ADX Families of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division | Approval for alternative tantalum capacitors. |
| P030054/S045 12/13/06 Real-Time |
St. Jude Medical™ Epic II/Epic II + and Atlas II/Atlas II + ICDs and CRT-D Systems | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for the following modifications to the ICD/CRT-D device hybrid: 1) addition of a new C64 micro controller integrated circuit (IC); 2) changes to the C46 VSS supply capacitor from 3.3 uF to 33 uF; and 3) changes to diodes D17, D19 and D23 in the protection circuit. |
| P030054/S046 12/14/06 Real-Time |
St. Jude Medical™ Epic DR/VR/HF, Epic+ DR/VR, Epic II/II+ DR/VR/HR, Atlas, Atlas+, and Atlas II/II+ ICD Systems |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for: 1) A n alternate electrolyte (TM422) in the high voltage capacitor used in the St. Jude Medical Epic DR/VR/HF, Epic+ DR/VR and Epic II/II + DR/VR/HF devices; and 2) The minor modifications to the crystal tuning fork used in Epic, Epic+, Epic II/II +, Atlas, Atlas+, Atlas II/II + devices. |
| P040001/S001 12/8/06 180-Day |
X-STOP® Interspinous Process Decompression (IPD) System | St. Francis Medical Technologies, Inc. Alameda, CA 94501 |
Approval of the post-approval study. |
| P040016/S012 12/21/06 135-Day |
Liberté Coronary Stent System | Boston Scientific Corporation Cardiovascular Division Maple Grove, MN 55311 |
Approval for an additional sterilization chamber at a contract sterilization facility. |
| P040016/S016 12/11/06 135-Day |
Liberté MR & OTW Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a heat shrink change for the proximal and midshaft welds. |
| P040034/S006 12/4/06 180-Day |
DuraSeal® Dural Sealant System | Confluent Surgical, Inc. Waltham, MA 02451 |
Approval for the removal of the following sentence in the indication statement: “DuraSeal should only be used with autologous duraplasty material.” |
| P040036/S001 12/4/06 180-Day |
Navistar Thermocool Ablation Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval of the post-approval study. |
| P040048/S001 12/28/06 180-Day |
Trilogy AB® Acetabular System | Zimmer, Inc. Warsaw, IN 46581 |
Approval for a manufacturing site located at Zimmer, Inc., Warsaw, Indiana for design control, final packaging and labeling of the ceramic acetabular shell components and approval for a sterilization site located at Sterigenics US LLC, Westerville, Ohio. |
| P050006/S002 12/13/06 180-Day |
Gore Helex Septal Occluder | W.L. Gore & Associates | Approval of the post-approval study. |
| P050023/S001 12/7/06 180-Day |
Lumax Implantable Cardioverter Defibrillators (ICDs): Models 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T and 340 HF-T and CardioMessenger II and Programmer Software Version 603.U for use with Lumax family of ICDs, Biotronik, Inc. pacers, single chamber ICDs and dual chamber ICDs | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Lumax Implantable Cardioverter Defibrillators (ICDs), Models 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T and 340 HF-T and Programmer Software Version 603.U for use with the Lumax family of ICDs and Biotronik, Inc. pacers, single chamber ICDs and dual chamber ICDs. The device, as modified, will be marketed under the trade name Lumax, and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and/or for providing treatment of congestive heart failure. |
| P810006/S025 12/19/06 |
CollaStat® Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Change in manufacturing equipment. |
| P810031/S032 12/1/06 |
Sodium Hyaluronate Ophthalmic Viscoelastic Devices – Healon®, Healon GV®, and Healon5® | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change to release final product by parametric release. |
| P850010/S022 12/19/06 |
Helistat® Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Change in manufacturing equipment. |
| P850051/S064 12/11/06 |
Legacy SR | Medtronic, Inc. Shoreview, MN 66126 |
Addition of a paperless chart recorder to the sterilization operations. |
| P890003/S113 12/11/06 |
Legacy DR, Wrench Accessory Kit | Medtronic, Inc. Shoreview, MN 66126 |
Addition of a paperless chart recorder to the sterilization operations. |
| P900061/S070 12/11/06 |
Active Can Emulator Connector, Transverse Epicardial Defibrillation Lead, Lead Sleeve Adapter Kit | Medtronic, Inc. Shoreview, MN 66126 |
Addition of a paperless chart recorder to the sterilization operations. |
| P910077/S067 12/6/06 |
MINI Implantable Cardioverter Defibrillators (ICDs) | Guidant Corporation Saint Paul, MN 55112 |
Additional incoming acceptance test specification. |
| P920015/S036 12/11/06 |
Pin Plug, DF-1 Y-Adapter/ Extender, Lead Assembly Silicone Defibrillator CS-D-1, 6.5 mm End Caps, Adapter |
Medtronic, Inc. Shoreview, MN 66126 |
Addition of a paperless chart recorder to the sterilization operations. |
| P920023/S019 12/5/06 |
Urolume Urethral Stent | American Medical Systems Minnetonka, MN 55343 |
Add a second in-process cytotoxicity testing site. |
| P940031/S060 12/6/06 |
MERIDIAN / DISCOVER Pacemakers | Guidant Corporation Saint Paul, MN 55112 |
Additional incoming acceptance test specification. |
| P950020/S021 12/6/06 |
Flextome Cutting Balloon Monorail & Over-The-Wire | Boston Scientific San Diego, CA 92123 |
Use of a Carbolite oven in the Letterkenny, Ireland facility to cure the MDX coating on balloon folders. |
| P950020/S022 12/14/06 |
Flextome Cutting Balloon Monorail & Over-The-Wire | Boston Scientific San Diego, CA 92123 |
Use of a new blade placement machine. |
| P960013/S024 12/11/06 |
Tendril® Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Revision to the weld process of the inner coil to the shaft coupling/spring assembly. |
| P960040/S136 12/6/06 |
PRIZM/VITALITY Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) | Guidant Corporation Saint Paul, MN 55112 |
Additional incoming acceptance test specification. |
| P960040/S137 12/21/06 |
VITALITY Cardiac Resynchronization Therapy Defibrillator (CRT-D) | Guidant Corporation Saint Paul, MN 55112 |
Change in the oven curing cycle for hybrid assemblies for the CONTAK RENEWAL and VITALITY family of ICDs. |
| P960040/S139 12/21/06 |
VITAITY ICDs | Guidant Corporation Cardiac Rhythm Division St. Paul, MN 55112 |
Change from cable operated anchor post spotweld equipment to pneumatically operated anchor post spotweld equipment. |
| D970003/S082 12/6/06 |
PULSAR/ DISCOVERY II/ INSIGNIA Pacemakers | Guidant Corporation Saint Paul, MN 55112 |
Additional incoming acceptance test specification. |
| P970012/S026 12/21/06 |
Kappa 400 | Medtronic, Inc. Shoreview, MN 55126 |
Changes in the manufacturing flow for the final device assembly for implantable pulse generators. |
| D970012/S033 12/5/06 |
AMS/Ambicor 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Add a second in-process cytotoxicity testing site. |
| P980035/S067 12/21/06 |
Kappa 700, Kappa 900, EnPulse, Adapta/Versa/ Sensia | Medtronic, Inc. Shoreview, MN 55126 |
Changes in the manufacturing flow for the final device assembly for implantable pulse generators. |
| P990052/S014 12/14/06 |
Vibrant® Soundbridge® Implantable Middle Ear Hearing Device (IMEHD) | MED-EL Corporation Durham, NC 27713 |
Establish Cendres & MÉTAUX SA as a second source supplier for the titanium housing of the floating mass transducer (FMT – a functional component of Vibrating Ossicular Prosthesis (VORP)). |
| P000053/S006 12/5/06 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka, MN 55343 |
Add a second in-process cytotoxicity testing site. |
| P010012/S143 12/6/06 |
CONTAK RENEWAL Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) | Guidant Corporation Saint Paul, MN 55112 |
Additional incoming acceptance test specification. |
| P010012/S144 12/21/06 |
CONTAK RENEWAL 3 Dual Chamber Implantable Pulse Generator | Guidant Corporation Saint Paul, MN 55112 |
Change in the oven curing cycle for hybrid assemblies for the CONTAK RENEWAL and VITALITY family of ICDs. |
| P010012/S145 12/21/06 |
CONTAK RENEWAL CRT-Ds |
Guidant Corporation Cardiac Rhythm Division St. Paul, MN 55112 |
Change from cable operated anchor post spotweld equipment to pneumatically operated anchor post spotweld equipment. |
| P010014/S011 12/15/06 |
Oxford Meniscal Unicompartmental Knee System | Biomet Orthopedics, Inc. Warsaw, IN 46582 |
Change in the minimum and maximum parameters for the dwell time during the heat sealing f blister packs. |
| P010019/S005 12/19/06 |
O 2 Optix™ (lotrafilcon B) Soft Contact Lenses | CIBA Vision Corporation Duluth, CA 30097 |
Implement a new Advanced Tool System (ATS) to increase production for the lotrafilcon B contact lenses. |
| P010020/S003 12/5/06 |
Acticon Neosphincter Artificial Bowel Sphincter | American Medical Systems Minnetonka, MN 55343 |
Add a second in-process cytotoxicity testing site. |
| P010055/S003 12/21/06 |
ProstaLund Operations AB CoreTherm System Microwave Thermotherapy for BPH | ProstaLund Operations AB Lund, Sweden SE-226 60 |
Change in the material used in the tip of the catheter component of the device. |
| P020004/S016 12/6/06 |
Gore Excluder® AAA Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
Change from a manual to a machine trim process. |
| P020018/S019 12/6/06 |
Zenith® AAA Endovascular Graft with H&L-B One-Shot™ Introduction System | Cook, Inc. Bloomington, IN 47402 |
Use of a contract manufacturer for the main body graft subassembly. |
| P020018/S020 12/6/06 |
Zenith® AAA Endovascular Graft with H&L-B One-Shot™ Introduction System | Cook, Inc. Bloomington, IN 47402 |
Use of an outside supplier for machining of the threaded top cap. |
| P030005/S040 12/6/06 |
CONTAK RENEWAL TR Pulse Generators | Guidant Corporation Saint Paul, MN 55112 |
Additional incoming acceptance test specification. |
| P040001/S004 12/29/06 |
X-Stop Interspinous Process Decompression System | St. Francis Medical Technologies, Inc. Alameda, CA 94501 |
Transfer of receiving, inspection, acceptance of finished goods, warehousing and distribution functions to the new headquarters facility. |
| P040006/S003 12/15/06 |
Charite Artificial Disc | DePuy Spine, Inc. Raynham, MA 12767 |
Addition to the Depuy ( Ireland) Ltd. Facility of an Optimal In-process Cleanline and three new pieces of equipment: a Mazak Integrex Machining Centre, a Schlick Blast Unit and a Trumpf Laser-marking Machine. |
| P040012/S024 12/14/06 |
Rx Acculink and Acculink Carotid Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Addition of an inspection step. |
| P050012/S005 12/26/06 |
DexCom™ STS™ System | DexCom, Inc. San Diego, CA 92121 |
Automation of the Final Release Test procedure for release of the STS Receiver. |
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 50
Summary of PMA Originals Under Review
Total Under Review: 80
Total Active: 37
Total On Hold: 43
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 437
Total Active: 237
Total On Hold: 200
Number Greater Than 180 Days: 15
Summary of All PMA Submissions Received
Originals: 6
Supplements:106
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 50
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 103.0
FDA Time: 76.5 Days MFR Time: 26.5 Days
Updated July 25, 2007
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