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.
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P070005 3/6/09 |
REPEL-CV® Bioresorbable Adhesion Barrier | Target Health, Inc. New York , NY 10016 |
Approval for the REPEL-CV® Bioresorbable Adhesion Barrier. The device is indicated for reducing the severity of post-operative cardiac adhesions in pediatric patients who are likely to require reoperation via sternotomy. |
| P080002 3/10/09 |
FC2 Female Condom | The Female Health Co. Chicago , IL 60610 |
Approval for the FC2 Female Condom. The device is indicated for preventing pregnancy, HIV/AIDS, and other sexually transmitted infections (STIs). |
| P080014 3/12/09 |
Cervista™ HPV HR and Genfind™ DNA Extraction Kit | Third Wave Technologies, Inc. Madison , WI 53719 |
Approval for the Cervista™ HPV HR and Genfind™ DNA Extraction Kit. Cervista™ HPV HR Indications For Use: The Cervista™ HPV HR test is an in vitro diagnostic test for the qualitative detection of DNA from 14 high-risk- Human Papillomavirus (HPV) types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) in cervical specimens. The Cervista™ HPV HR test cannot determine the specific HPV type present. The Cervista™ HPV HR test uses the Invader® chemistry, a signal amplification method for detection of specific nucleic acid sequences. This method uses two types of isothermal reactions: a primary reaction that occurs on the targeted DNA sequence and a secondary reaction that produces a fluorescent signal. The Cervista™ HPV HR test is indicated: 1) To screen patients with atypical squamous cells of undetermined significance (ASCUS) cervical cytology results to determine the need for referral to colposcopy. 2) In women 30 years and older the Cervista™ HPV HR test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the Cervista™ HPV HR test include the following preservation system collection media and collection devices: • ThinPrep® Pap Test™ PreservCyt® Solution • Broom-type device (e.g. Rovers Cervex Brush, Wallach Papette), or Endocervical Brush/Spatula. Genfind™ DNA Extraction Kit Indication For Use: The Genfind™ DNA Extraction Kit is intended for use in the extraction of DNA from cervical specimens collected in ThinPrep® Pap Test™ PreservCyt® Solution for testing by the Cervista™ HPV HR and Cervista™ HPV 16/18 tests. |
| P080015 3/12/09 |
Cervista™ HPV 16/18 | Third Wave Technologies, Inc. Madison , WI 53719 |
Approval for the Cervista™ HPV 16/18. Cervista™ HPV 16/18 Indications For Use: The Cervista™ HPV 16/18 test is an in vitro diagnostic test for the qualitative detection of DNA from Human Papillomavirus (HPV) Type 16 and Type 18 in cervical specimens. The Cervista™ HPV 16/18 test uses the Invader® chemistry, a signal amplification method for detection of specific nucleic acid sequences. This method uses two types of isothermal reactions: a primary reaction that occurs on the targeted DNA sequence and a secondary reaction that produces a fluorescent signal. Cervista™ HPV 16/18 test is indicated: 1) In women 30 years and older the Cervista™ HPV 16/1S test can be used adjunctively with the Cervista™ HPV HR test in combination with cervical cytology to screen to assess the presence or absence of high-risk HPV types 16 and 18. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. 2) To be used adjunctively with the Cervista™ HPV HR test in patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, to assess the presence or absence of high-risk HPV types 16 and 18. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. Cervical specimens that may be tested with the Cervista™ HPV 16/18 test include the following preservation system and collection devices: ThinPrep® Pap Test™ PreservCyt® Solution; and • Broom-type device (e.g. Rovers Cervex Brush, Wallach Papette), or Endocervical Brush/Spatula. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790017/S100 3/12/09 180-Day |
NC Sprinter Rapid Exchange Balloon Dilatation Catheter | Medtronic Vascular Santa Rosa , CA 95403 |
Approval for a manufacturing site located at Medtronic Mexico, in Tijuana Mexico. |
| P810006/S032 3/26/09 180-Day |
CollaStat® Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro , NJ 08536 |
Approval for an alternate production facility located at Integra Neurosciences PR, Inc., for several production steps for the devices. |
| P820003/S086 3/9/09 135-Day |
Model 5433 Cable | Medtronic, Inc. Mounds View MN 55112 |
Approval for a change in the Model 5433 cable inspection level. |
| P840062/S018 3/26/09 180-Day |
CollaCote Absorbable Collagen Wound Dressing | Integra LifeSciences Corporation Plainsboro , NJ 08536 |
Approval for an alternate production facility located at Integra Neurosciences PR, Inc., for several production steps for the devices. |
| P850010/S029 3/26/09 180-Day |
HeliStat® Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro , NJ 08536 |
Approval for an alternate production facility located at Integra Neurosciences PR, Inc., for several production steps for the devices. |
| P860003/S048 3/20/09 180-Day |
Therakos Cellex Photopheresis System | Therakos, Inc. Exton , PA 19341 |
Approval for engineering and design changes to the UVAR® XTS™ Photopheresis System. The device, as modified, will be marketed under the trade name Therakos Cellex Photopheresis System, and is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other forms of treatment. |
| P860004/S104 3/13/09 Real-Time |
SynchroMed Infusion System | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for updated MRI Warning, changes to the Needle Hub, and changes to the Y-Connector for the drug refill kits. |
| P870078/S006 3/25/09 180-Day |
Hancock® Porcine Bioprosthetic Valved Conduit and Hancock® Trocar Blades and Handle | Medtronic Heart Valves Santa Ana , CA 92705 |
Approval for the addition of the Hancock® Porcine Bioprosthetic Valved Conduit and Hancock® Trocar Blades and Handle. |
| P900009/S030 3/13/09 135-Day |
Exogen 4000+ Bone Healing System | Smith & Nephew, Inc. Memphis , TN 38116 |
Approval for an alternate supplier for the manufacturing of the printed circuit board assembly (PCBA). |
| P900023/S049 3/17/09 180-Day |
AB Portable Driver | Abiomed, Inc. Danvers , MA 01923 |
Approval for in-hospital use of the device. |
| P910001/S027 3/25/09 135-Day |
CVX-300 Excimer Laser Coronary Angioplasty System | Spectranetics Corporation Colorado Springs , CO 80921 |
Approval for: 1) removal of bioburden testing from the Lot History Records (LHR) as a test required for release of product, and 2) Change LAL Endotoxin test procedure to instruct quality associates to collect product sample post-sterilization. |
| P910018/S012 3/31/09 180-Day |
Liposorber® LA-15 System | Kaneka Pharma America LLC New, York, NY 10036 |
Approval for the Liposorber® LA-15 System using the MA-03 Apheresis Machine and the Blood Tubing Systems; NK-M3R and NK-M1R. |
| P910023/S202 3/23/09 Real-Time |
C64 IC (Version P) for the Epic II / Atlas II Platform of ICDs, and SIO2 IC (Version G) for the Epic+ / Atlas+ and Epic II / Atlas II Platform of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 91342 |
Approval for the modifications of the C64 IC (Version P) for the Epic II / Atlas II Platform of ICDs, and SIO2 IC (Version G) for the Epic+ / Atlas+ and Epic II / Atlas II Platform of ICDs. |
| P920014/S029 3/13/09 180-Day |
Thoratec® HeartMate® XVE Left Ventricular Assist System (LVAS) | Thoratec Corporation Burlington , MA 01803 |
Approval for modifications to the external peripherals. |
| P950015/S011 3/8/09 180-Day |
The Heart Laser CO 2 TMR System | PLC Medical Systems, Inc. Franklin , MA 02038 |
Approval for changes made to the labeling as a result of completion of the post-approval study. |
| P950022/S054 3/26/09 135-Day |
Riata and Durata Family of Leads | St. Jude Medical, Inc. Sylmar , CA 91342 |
Approval for an alternate supplier. |
| P950037/S067 3/31/09 180-Day |
Model ICS 3000 802.U/2 Programmer Software | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for: 1) commercial distribution of the Lumax HF-T CRT-Ds and Stratos LV (-T) CRT-Ps with ventricle to ventricle (V-V) delay features; and 2) updated Model ICS 3000 programmer software (release of 802.U/2) to implement the V-V delay features and other minor enhancements. |
| P960009/S051 3/27/09 180-Day |
Activa RC Rechargeable Implantable Neurostimulation System | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the following new components and accessories for the Activa RC Rechargeable Implantable Neurostimulation System: • Activa RC, Model 37612 (Neurostimulator) • Patient Programmer, Model 37642 • Model 8870 Application Card (Activa RC) • External Neurostimulator, Model 37022 • 8-4 Extension, Model 37085 • Alligator Clip Screening Cable. Model 3550-67 • Twist Lock Screening Cable, Model 3550-68 The Activa RC Rechargeable Implantable Neurostimulation System is indicated as follows: Medtronic Activa Therapy includes Activa Parkinson's Control Therapy and Activa Tremor Control Therapy. Parkinson's Control Therapy Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Tremor Control Therapy Unilateral thalamic stimulation by the Medtronic Activa Tremor Control System is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with Essential Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. |
| P960040/S190 3/18/09 Real-Time |
Teligen and Confient ICD Systems | Boston Scientific Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for modifications to the setscrew design, seal plug design, labeling for the torque wrench, and the Model 6628 Torque Wrench Accessory Kit as a stand alone accessory. |
| P960042/S010 3/25/09 135-Day |
CVX-300 Excimer Laser V3.7.12/V3.8.12 | Spectranetics Corporation Colorado Springs , CO 80921 |
Approval for: 1) removal of bioburden testing from the Lot History Records (LHR) as a test required for release of product, and 2) Change LAL Endotoxin test procedure to instruct quality associates to collect product sample post-sterilization. |
| P960058/S074 3/11/09 135-Day |
HiResolution Bionic Ear System | Advanced Bionics Sylmar , CA 91342 |
Approval to change to the platinum solid ring. |
| P960058/S079 3/18/09 Real-Time |
Harmony HiResolution Bionic Ear System | Advanced Bionics, LLC Sylmar , CA 91342 |
Approval for the HiRes 90K Mock-Up as sterile instead of non-sterile, and to establish the shelf life at three years. The device, as modified, will be marketed under the trade name Harmony HiResolution Bionic Ear System HiRes 90K Mock-Up (Mock-UP) and is indicated for individuals aged twelve months and older with severe-to profound sensorineural hearing loss via electrical stimulation of the auditory nerve. |
| P970003/S106 3/6/09 180-Day |
VNS Therapy™ System | Cyberonics, Inc. Houston , TX 77058 |
Approval for changing the trade name of the VNS Therapy™ Perennia™ Model 303 Lead to VNS Therapy™ PerenniaDURA™ Model 303 Lead. |
| D970003/S109 3/18/09 Real-Time |
Altrua Pacemaker System | Boston Scientific Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for modifications to the setscrew design, seal plug design, labeling for the torque wrench, and the Model 6628 Torque Wrench Accessory Kit as a stand alone accessory. |
| P980016/S159 3/9/09 135-Day |
Virtuoso ICD | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for modifications to the hybrid press fixture. |
| P980016/S164 3/31/09 180-Day |
Medtronic® Secura™ DR/VR D224DRG/ D224VRC, Maximo® II DR/VR D284DRG/ D284VRC, Virtuoso II DR/VR D274DRG/ D274VRC Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Model 9995 v1.2 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for the Model 9995 v1.2 application software which includes the Lead Integrity Alert feature and additional software updates. |
| P980016/S175 3/11/09 Real-Time |
Virtuoso II DR/VR Models D274DRG/ D274VRC, Secura DR/VR D224DRG/ D224VRC, Maximo II DR/VR Models D284DRG/ D284VRC Implantable Devices |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for the following minor design changes: 1) Two (2) IC design changes • L310 and L354 2) Two (2) Alternate components • Diode change (Currently: XD423 and Proposed: XD445) • Insulated-Gate Bipolar Transistor (IGBT) change (Currently: XD405 and Proposed: XD447) 3) Printed Wire Board (PWB) changes to accommodate the alternate (XD445 diode and XD447 IGBT) components and manufacturability improvements. 4) Four (4) ICs (L303, L310, L354, and L409) to be transferred to an alternative IC fabrication vendor. |
| P980016/S178 3/16/09 Real-Time |
Entrust Family of ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Approval for design changes to the 6-pin filtered feedthrough (FFT) used in the EnTrust ICD devices. |
| P980023/S036 3/31/09 180-Day |
Model ICS 3000 802.U/2 Programmer Software | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for: 1) commercial distribution of the Lumax HF-T CRT-Ds and Stratos LV (-T) CRT-Ps with ventricle to ventricle (V-V) delay features; and 2) updated Model ICS 3000 programmer software (release of 802.U/2) to implement the V-V delay features and other minor enhancements. |
| P980037/S027 3/19/09 180-Day |
AngioJet® Rheolytic Thrombectomy System | Medrad Interventional/ Possis Minneapolis , MN 55433 |
Approval for the AngioJet Ultra Console Software Version V1.1. |
| P990075/S021 3/31/09 180-Day |
Saline-Filled Breast Implants and Spectrum® Post-Operatively Adjustable Saline-Filled Breast Implants | Mentor Corporation Santa Barbara , CA 93111 |
Approval for revised labeling that reflects 10-year post-approval study data. |
| P000009/S030 3/12/09 135-Day |
Lexos and Lumos Families of ICDs | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for changing the ICD battery pre-discharging process. |
| P000009/S032 3/31/09 180-Day |
Model ICS 3000 802.U/2 Programmer Software | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for: 1) commercial distribution of the Lumax HF-T CRT-Ds and Stratos LV (-T) CRT-Ps with ventricle to ventricle (V-V) delay features; and 2) updated Model ICS 3000 programmer software (release of 802.U/2) to implement the V-V delay features and other minor enhancements. |
| P000027/S005 3/3/09 180-Day |
Roche Diagnostics Elecsys® Free PSA Immunoassay, CalSet, CalCheck | Roche Professional Diagnostics Indianapolis , IN 46250 |
Approval for extension of the Elecsys® total PSA system onto an updated model of the Modular Analytics E170 analyzer, known as the cobas® e411 analyzer. |
| P000032/S028 3/27/09 180-Day |
Her Option® | American Medical Systems, Inc. Minnetonka , MN 55343 |
Approval for a modification to the labeling the Her Option® to include the results of the clinical study conducted to investigate the safety and effectiveness of the extended treatment regimen (ETR). |
| P000049/S016 3/5/09 180-Day |
CardioSEAL® and STARFlex® Septal Occlusion Systems with Qwik Load™ | NMT Medical, Inc Boston , MA 02210 |
Approval for the addition of the STARFlex® VSD Occluder in three sizes. The device, as modified, will be marketed under the trade name STARFlex® Septal Occluder and is indicated for use in patients with a complex ventricular septal defect (VSD) of a significant size to warrant closure, but that based on location, cannot be closed with standard transatrial or transarterial approaches. |
| P010012/S203 3/18/09 Real-Time |
Cognis and Livian CRT-D Systems | Boston Scientific Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for modifications to the setscrew design, seal plug design, labeling for the torque wrench, and the Model 6628 Torque Wrench Accessory Kit as a stand alone accessory. |
| P010025/S015 3/16/09 Real-Time |
Selenia Full Field Digital Mammography System | Hologic, Inc. Danbury , CT 06810 |
Approval for a change to the image implant detection process. |
| P010031/S127 3/9/09 135-Day |
Concerto CRT-D | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for modifications to the hybrid press fixture. |
| P010031/S131 3/31/9 180-Day |
Medtronic® Consulta™ CRT-D D224TRK, Maximo® II CRT-D D284TRK, Concerto™ II D274TRK Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Model 9995 v1.2 Application Software | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for the Model 9995 v1.2 application software which includes the Lead Integrity Alert feature and additional software updates. |
| P010031/S141 3/11/09 Real-Time |
Concerto II Model D274TRK, Consulta Model D224TRK, Maximo II Model D284TRK Implantable Cardioverter Defibrillators |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for the following minor design changes: 1) Two (2) IC design changes • L310 and L354 2) Two (2) Alternate components • Diode change (Currently: XD423 and Proposed: XD445) • Insulated-Gate Bipolar Transistor (IGBT) change (Currently: XD405 and Proposed: XD447) 3) Printed Wire Board (PWB) changes to accommodate the alternate (XD445 diode and XD447 IGBT) components and manufacturability improvements. 4) Four (4) ICs (L303, L310, L354, and L409) to be transferred to an alternative IC fabrication vendor. |
| P010032/S028 3/19/09 180-Day |
Eon Mini IPG Neurostimulation System | Advanced Neuromodulation Systems, Inc. Plano , TX 75024 |
Approval for a manufacturing site at St. Jude Medical Puerto Rico, LLC, in Caguas, Puerto Rico. |
| P020004/S039 3/5/09 180-Day |
GORE EXCLUDER ® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 |
Approval for the addition of the 31 mm GORE EXCLUDER® Endoprosthesis. The 31 mm GORE EXCLUDERS Endoprosthesis includes two components that were not included in prior submissions: the 31 mm trunk-ipsilateral leg and the 32 mm Aortic Extender. The device, as modified, will be marketed under the trade name GORE EXCLUDERS AAA Endoprosthesis and is intended to exclude the aneurysm from blood circulation in patients who have appropriate anatomy as follows: 1) Adequate iliac/femoral access; 2) Infrarenal aortic neck treatment diameter range of 19-29 mm and a minimum aortic neck length of 15 mm; 3) Proximal aortic neck angulation less than or equal to 60 degrees; and 4) Iliac artery treatment diameter range of 8-18.5 mm and iliac distal vessel seal zone length of at least 10 mm. |
| P020014/S018 3/16/09 180-Day |
ESS305 | Conceptus, Inc. Mountainview , CA 94041 |
Approval of the post-approval study protocol. |
| P020014/S023 3/9/09 Real-Time |
Conceptus Essure® System for Permanent Birth Control | Conceptus, Inc. Mountain View , CA 94041 |
Approval of minor changes to the patient information booklet. |
| P020026/S050 3/23/09 135-Day |
Cypher® Sirolimus-eluting Coronary Stent on Raptor™ Over-the-Wire (OTW) and Raptorrail® Rapid Exchange (RX) Delivery Systems | Cordis Corporation Miami Lakes , FL 33014 |
Approval for a change of the transfer of stent trays during the spray coating unit operation from the current methodology to a continuous manner from the coating step to another. |
| P030017/S076 3/16/09 135-Day |
Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Corporation Sylmar , CA 91342 |
Approval for modifications to the linear lead assembly process. |
| P030017/S081 3/6/09 135-Day |
Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Corporation Sylmar , CA 91342 |
Approval for improvements in the implantable pulse generator (IPG) assembly process. |
| P030017/S088 3/20/09 180-Day |
Precision™ Spinal Cord Stimulation (SCS) System | Boston Scientific Corp. Valencia , CA 91355 |
Approval for a change in the manufacturing process of the 50 (SC-8216-50) and 70 cm (SC-8216-70) Artisan 2x8 Surgical Electrode Leads. |
| P030022/S010 3/6/09 180-Day |
Reflection® Ceramic Acetabular System | Smith & Nephew, Inc. Memphis , TN 38116 |
Approval for the revisions to the product label. |
| P030025/S059 3/20/09 135-Day |
TAXUS™ Express 2™ Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for changes to the size of the SIBS pieces and the process for mixing and filtering the spray coating solution used to manufacture the device. |
| P030054/S118 3/23/09 Real-Time |
C64 IC (Version P) for the Epic II / Atlas II Platform of ICDs, and SIO2 IC (Version G) for the Epic+ / Atlas+ and Epic II / Atlas II Platform of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 91342 |
Approval for the modifications of the C64 IC (Version P) for the Epic II / Atlas II Platform of ICDs, and SIO2 IC (Version G) for the Epic+ / Atlas+ and Epic II / Atlas II Platform of ICDs. |
| P040001/S013 3/11/09 180-Day |
X-STOP Interspinous Process | Medtronic Spine, LLC Sunnyvale , CA 94089 |
Approval of the post-approval study protocol. |
| P040003/S005 3/4/09 180-Day |
ExAblate® 2000 System | InSightec, Inc. Dallas , TX 75244 |
Approval for labeling and treatment protocol changes. The device, as modified, will continue to be marketed under the trade name ExAblate® 2000 and is indicated for ablation of uterine fibroid tissue in pre-or per-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure and whose uterine size is less than 24 weeks. Limited information is available regarding the safety and effectiveness of the ExAblate® as a treatment for women who desire pregnancy. Patients should have completed child bearing. |
| P040023/S011 3/4/09 135-Day |
Duraloc® Option Ceramic Hip System | DePuy Orthopaedics, Inc. Warsaw , IN 46581 |
Approval of a change to the design specification of a forging component for the Summit Hip femoral prosthesis. |
| P040028/S004 3/19/09 Real-Time |
LUMA Cervical Imaging System | SpectraScience, Inc. San Diego , CA 92121 |
Approval for extension of the shelf life of the LUMA probe cover from two years to three years. |
| P040038/S016 3/31/09 Real-Time |
Xact® Carotid Stent System | Abbott Vascular, Inc. Santa Clara , CA 95054 |
Approval for modifications to the packaging of the device. |
| P040043/S019 3/4/09 180-Day |
Gore TAG Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86002 |
Approval to update the Instructions for Use with clinical data on subjects with ruptured aneurysms of the descending thoracic aorta. |
| P040047/S011 3/11/09 135-Day |
Coaptite® Injectable Implant | BioForm Medical, Inc. Franksville , WI 53126 |
Approval for a second convection oven. |
| P050023/S017 3/12/09 135-Day |
Lumax Family of ICDs | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for changing the ICD battery pre-discharging process. |
| P050023/S019 3/31/09 180-Day |
Lumax 300 JR-T, Lumax 340 HR-T, Lumax 500 FY-T, and Lumax 540 HF-T Cardiac Resynchronization Therapy (CRT) Defibrillators (CRT-Ds) |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for: 1) commercial distribution of the Lumax HF-T CRT-Ds and Stratos LV (-T) CRT-Ps with ventricle to ventricle (V-V) delay features; and 2) updated Model ICS 3000 programmer software (release of 802.U/2) to implement the V-V delay features and other minor enhancements. |
| P060010/S003 3/10/09 Real-Time |
The Spanner™ Temporary Prostatic Stent | AbbeyMoor Medical, Inc. Parkers Prairie, MN 56361 |
Approval to add 45 degree curve in the distal portion of the stent. |
| P060025/S003 3/5/09 Real-Time |
ATS 3f Aortic Bioprosthesis | ATS Medical, Inc. Lake Forest , CA 92630 |
Approval for extension of the shelf-life of the ATS 3f Aortic Bioprosthesis, Model 1000 valves (sizes 19, 21, 23, 25, 27 and 29 mm) from 2 years to 5 years. The device is indicated for “..use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their valve with a prosthetic device. The usual conditions of advanced disease include aortic stenosis, aortic incompetence, and a combination of the two.” |
| P060027/S007 3/26/09 13-Day |
Situs Over-the-Wire (OTW) UW28D Left Ventricular Lead | ELA Medical, Inc. Plymouth , MN 55441 |
Approval to change the location for manufacturing the steroid component of the device. |
| P060027/S009 3/4/09 180-Day |
Ovatio Cardiac Resynchronization Therapy (CRT) | ELA Medical, Inc. Plymouth , MN 55441 |
Approval of the post-approval study protocol. |
| P060033/S011 3/2/09 180-Day |
Endeavor Zotarolimus-Eluting Coronary Stent System OTW, Multi-Exchange II (MX2), and Rapid Exchange (RX) Delivery System | Medtronic, Inc. Santa Rosa , CA 95403 |
Approval for a manufacturing site located at Medtronic Cardiovascular, Revascularization & Surgical Therapy in Brooklyn Park, Minnesota, for packaging and label rework of the device. |
| P060033/S026 3/20/09 135-Day |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic, Inc. Santa Rosa , CA 95403 |
Approval for removal of the Stent Securement Test as a final acceptance activity. |
| P060037/S005 3/26/09 180-Day |
Zimmer NexGen® LPS-Flex Mobile and LPS-Mobile Bearing Knee | Zimmer, Inc. Warsaw , IN 46581 |
Approval for changes to the NexGen Fluted Stem Mobile Tibial Component, resulting in the NexGen Minimally Invasive Solutions (MIS) LPS-Mobile Tibial Component. Changes made to the NexGen Fluted Stem Mobile Tibial Component include shortening the tibial baseplate stem and adding broad proximal fins, changing the outer profile radius of the baseplate edge from a variable radius to a constant radius, and adding an additional size (4-Plus) to the current range of sizes (1 - 8). |
| P060040/S001 3/13/09 180-Day |
Thoratec HeartMate II® Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton , CA 94588 |
Approval for new external peripherals to provide power and support operation for the device. |
| P070007/S004 3/23/09 180-Day |
Talent Thoracic Stent Graft System | Medtronic Vascular Santa Rosa , CA 95403 |
Approval for a manufacturing site located at Medtronic Mexico EG, Empalme, Mexico |
| P070007/S008 3/20/09 180-Day |
Talent Thoracic Stent Graft System | Medtronic Vascular Santa Rosa , CA 95403 |
Approval for a manufacturing site located at Medtronic Vascular Galway Limited, Galway, Ireland. |
| P070008/S008 3/31/09 180-Day |
Strator LV and Strator LV-T CRT Pacemakers (CRT-Ps) |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for: 1) commercial distribution of the Lumax HF-T CRT-Ds and Stratos LV (-T) CRT-Ps with ventricle to ventricle (V-V) delay features; and 2) updated Model ICS 3000 programmer software (release of 802.U/2) to implement the V-V delay features and other minor enhancements. |
| P070015/S010 3/11/09 Real-Time |
XIENCE V™ Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula , CA 92591 |
Approval for a 24-month shelf life. |
| P070027/S004 3/23/09 180-Day |
Talent Abdominal Stent Graft System | Medtronic Vascular Santa Rosa , CA 95403 |
Approval for a manufacturing site located at Medtronic Mexico EG, Empalme, Mexico |
| P070027/S006 3/13/09 180-Day |
Talent Abdominal Stent Graft System | Medtronic Vascular Santa Rosa , CA 95403 |
Approval for a manufacturing site located at Medtronic Vascular Galway Limited, Galway, Ireland. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| P820003/S089 3/6/09 |
Dual Chamber, Implantable Pulse Generator | Medtronic, Inc. Mounds View, MN 55112 |
Transferring the final in-process inspection and final packaging process steps for the Model 5409 Pouch-Disposable, 5PK to the contract manufacturer’s facility in Medina, Minnesota. |
| P820003/S090 3/9/09 |
Dual Chamber Implantable Pulse Generator | Medtronic, Inc. Mounds View, MN 55112 |
Transfer of the final in-process inspection and final packaging process steps from Medtronic Rice Creek facility to the contract manufacturer. |
| P830061/S045 3/6/09 |
CapSure, CapSure SP, CapSure SP Novus, CapSure Sense, Vitatron Excellence+, Vitatron Excellence PS+, and Vitatron Crystalline |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of a supplier for an extruded component used to manufacture adhesive. |
| P840001/S129 3/2/009 |
Spinal Cord Family of Neurostimulation Leads | Medtronic Neuromodulation Minneapolis , MN 55432 |
Alternate supplier for an extruded tubing component. |
| P840001/S130 3/12/09 |
Itrel 3 Implantable Pulse Generator, Synergy Family of Implantable Neurostimulators and Restore Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis , MN 55432 |
Change in the in-line manufacturing test for seam weld leak test inspection procedure. |
| P840001/S132 3/19/09 |
Restore Family of Neurostimulator Systems | Medtronic Neuromodulation Minneapolis , MN 55432 |
Change to the resistance welding operation. |
| P850089/S061 3/6/09 |
CapSure Z, CapSure Z Novus, CapSure SP Novus, Vitatron Impulse II, Vitatron Impulse, and Vitatron Excellence SS+ |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of a supplier for an extruded component used to manufacture adhesive. |
| P890003/S163 3/6/09 |
CapSure VDD-2 and Brilliant S+ | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a supplier for an extruded component used to manufacture adhesive. |
| P890003/S167 3/26/09 |
CareLink® Monitors | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the inline quality test systems. |
| P900007/S006 3/5/09 |
Cook® Chorionic Villus Sampling Set | Cook Ob/Gyn Spencer , IN 47460 |
Modification to the obturator handle and the technique for affixing it to the obturator wire. |
| P920015/S052 3/6/09 |
Sprint, Sprint Quattro, and Sprint Quattro Secure | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a supplier for an extruded component used to manufacture adhesive. |
| P930014/S031 3/16/09 |
AcrySof® Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. Fort Worth , TX 76134 |
Introduction of an expiration date for Perkadox-16. |
| P930039/S030 3/6/09 |
CapSureFix, CapSureFix Novus, Vitatron Pirouet S+, Vitatron Crystalline ActFix | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a supplier for an extruded component used to manufacture adhesive. |
| P940015/S014 3/11/09 |
Synvic® and Synvisc-One™ (hylan G-F 20) | Genzyme Corporation Cambridge , MA 02142 |
Removal of the cytotoxicity test (USP<87> biological reactivity test, in vitro) from the hylan B-10 gel in-process specification for the device. |
| P950021/S010 3/6/09 |
ADVIA Centaur PSA Assay | Siemens Healthcare Diagnostics Tarrytown , NY 10591 |
Change involving the conjugated antibodies for the device. |
| P950024/S016 3/6/09 |
CapSure Epicardial Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a supplier for an extruded component used to manufacture adhesive. |
| P950032/S050 3/13/09 |
Apligraf | Organogenesis, Inc. Canton , MA 02021 |
Implementation of a new assay for the determination of collagen in Apligraf. |
| P960009/S062 3/2/009 |
Deep Brain Stimulation Family of Neurostimulation Leads | Medtronic Neuromodulation Minneapolis , MN 55432 |
Alternate supplier for an extruded tubing component. |
| P960009/S063 3/12/09 |
Soletra Neurostimulator and Kinetra Neurostimulator | Medtronic Neuromodulation Minneapolis , MN 55432 |
Change in the in-line manufacturing test for seam weld leak test inspection procedure. |
| P960009/S064 3/19/09 |
Activa Therapy DBS | Medtronic Neuromodulation Minneapolis , MN 55432 |
Change to the resistance welding operation. |
| P960040/S189 3/12/09 |
Teligen™ ICD | Boston Scientific Corporation St. Paul , MN 55112 |
Additional supply source for low voltage capacitors to the device family. |
| P960040/S191 3/31/09 |
Teligen | Boston Scientific Corporation St. Paul , MN 55112 |
Second source supplier for headers. |
| P960058/S078 3/5/09 |
HiResolution Bionic Ear System | Advanced Bionics Sylmar , CA 91342 |
Addition of visual acceptance criteria to the Receiving Inspection Instruction. |
| P970004/S070 3/2/09 |
InterStim Family of Neurostimulation Leads | Medtronic Neuromodulation Minneapolis , MN 55432 |
Alternate supplier for an extruded tubing component. |
| P970004/S071 3/12/09 |
InterStim Family of Neurostimulation Leads | Medtronic Neuromodulation Minneapolis , MN 55432 |
Change in the in-line manufacturing test for seam weld leak test inspection procedure. |
| P970008/S043 3/5/09 |
Urologix Targis® System for the treatment of BPH | Urologix, Inc. Minneapolis , MN 55447 |
Changes to the ethylene oxide sterilization process used on the Targis® System components. |
| D970012/S060 3/19/09 |
AMS 700™ Series Inflatable Penile Prosthesis | American Medical Systems Minnetonka , MN 55343 |
Change in the tubing/pump connection tolerances. |
| D970012/S061 3/19/09 |
AMS 700™ Series Inflatable Penile Prosthesis | American Medical Systems Minnetonka , MN 55343 |
Implementation of a back-up in-process tester. |
| D970012/S062 3/19/09 |
AMS 700™ Series Inflatable Penile Prosthesis | American Medical Systems Minnetonka , MN 55343 |
Alternate mixing vessel to be used in the manufacture of a solution. |
| D970012/S063 3/23/09 |
AMS 700™ Series Inflatable Penile Prosthesis | American Medical Systems Minnetonka , MN 55343 |
Use of an additional, duplicate strain relief mold. |
| P970054/S007 3/3/09 |
Parvovirus B19 IgG In Vitro Diagnostic Device. | Biotrin International, Ltd. Dublin , Ireland |
Removal of Day 7 Drop Off testing and related specification. |
| P970055/S007 3/3/09 |
Parvovirus B19 IgM In Vitro Diagnostic Device. | Biotrin International, Ltd. Dublin , Ireland |
Removal of Day 7 Drop Off testing and related specification. |
| P980016/S177 3/6/09 |
CapSureFix | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a supplier for an extruded component used to manufacture adhesive. |
| P980016/S182 3/24/09 |
Model 174105, 2PK Magnets and Model 9466, 4PK Magnets | Medtronic, Inc. Mounds View, MN 55112 |
Transfer of processes to a contract manufacturing facility. |
| P980035/S127 3/3/09 |
Adapta, Versa, Sensia and Relia IPGs | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Changes to the test software and hardware for the Final Functional test. |
| P980050/S040 3/6/09 |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a supplier for an extruded component used to manufacture adhesive. |
| P990013/S025 3/11/09 |
STAAR Surgical Collamer® UV Absorbing Posterior Chamber Intraocular Lenses | STAAR Surgical Company Monrovia , CA 91016 |
Addition of a new refrigerator at the Aliso Viejo facility. |
| P990046/S020 3/24/09 |
ATS 3f® Open Pivot Heart Valve | ATS Medical, Inc. Lake Forest , CA 92630 |
Alternate location for assembly of the sewing cuff component at the Lake Forest facility. |
| P990055/S011 3/6/09 |
ADVIA Centaur cPSA Assay | Siemens Healthcare Diagnostics Tarrytown , NY 10591 |
Change involving the conjugated antibodies for the device. |
| P990074/S021 3/3/09 |
Allergan Saline-Filled Breast Implants | Allergan Goleta , CA 93117 |
Change in the supplier of components for the manufacture of the device. |
| P000014/S018 3/19/09 |
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
New automated procedure for confirming the volume of coating solution dispensed into the microtiter wells. |
| P000025/S040 3/25/09 |
MED-EL COMBI 40+ Cochlear Implant System | MED-EL Corporation Durham , NC 27713 |
Addition of a second supplier for the electrode wires. |
| P000026/S002 3/11/09 |
STAAR Surgical AquaFlow® Collagen Glaucoma Drainage Device | STAAR Surgical Company Monrovia , CA 91016 |
Addition of a new refrigerator at the Aliso Viejo facility. |
| P000044/S021 3/19/09 |
VITROS Immunodiagnostic Products Anti-HBsAg Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
New automated procedure for confirming the volume of coating solution dispensed into the microtiter wells. |
| P000053/S021 3/19/09 |
AMS 800® Urinary Control System | American Medical Systems Minnetonka , MN 55343 |
Implementation of a back-up in-process tester. |
| P000053/S022 3/19/09 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka , MN 55343 |
Alternate mixing vessel to be used in the manufacture of a solution. |
| P0100012/S202 3/12/09 |
Cognis™ CRT-D | Boston Scientific Corporation St. Paul , MN 55112 |
Additional supply source for low voltage capacitors to the device family. |
| P010012/S204 3/31/09 |
Cognis | Boston Scientific Corporation St. Paul , MN 55112 |
Second source supplier for headers. |
| P010015/S061 3/6/09 |
Attain LV and Attain CS | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a supplier for an extruded component used to manufacture adhesive. |
| P010021/S015 3/19/09 |
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
New automated procedure for confirming the volume of coating solution dispensed into the microtiter wells. |
| P030005/S056 3/11/09 |
Contak Renewal TR Pulse Generators | Boston Scientific St. Paul , MN 55112 |
Movement of the hybrid subcomponent assembly from the Minnesota facility to Clonmel, Ireland. |
| P030009/S033 3/4/09 |
Driver and MicroDriver Coronary Stent System | Medtronic Vascular Santa Rosa , CA 95403 |
Change to update the Metallographic test method. |
| P030016/S012 3/11/09 |
STAAR Surgical Implantable Collamer® Lens for Myopia | STAAR Surgical Company Monrovia , CA 91016 |
Addition of a new refrigerator at the Aliso Viejo facility. |
| P030024/S011 3/19/09 |
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
New automated procedure for confirming the volume of coating solution dispensed into the microtiter wells. |
| P030026/S017 3/19/09 |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
New automated procedure for confirming the volume of coating solution dispensed into the microtiter wells. |
| P030036/S012 3/6/09 |
SelectSecure® System | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a supplier for an extruded component used to manufacture adhesive. |
| P030040/S003 3/4/09 |
ADVIA Centaur HBcIgM | Siemens Healthcare Diagnostics Tarrytown , NY 10591 |
Change involving the manufacturing of (biotinlated) antibody and antigen. |
| P030049/S003 3/4/09 |
ADVIA Centaur HBsAg | Siemens Healthcare Diagnostics Tarrytown , NY 10591 |
Change involving the manufacturing of (biotinlated) antibody and antigen. |
| P030056/S003 3/4/09 |
ADVIA Centaur HCV | Siemens Healthcare Diagnostics Tarrytown , NY 10591 |
Change involving the manufacturing of (biotinlated) antibody and antigen. |
| P040004/S003 3/4/09 |
ADVIA Centaur HBcT | Siemens Healthcare Diagnostics Tarrytown , NY 10591 |
Change involving the manufacturing of (biotinlated) antibody and antigen. |
| P040020/S013 3/16/09 |
ReSTOR® Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. Fort Worth , TX 76134 |
Introduction of an expiration date for Perkadox-16. |
| P040024/S034 3/4/09 |
Restylane® and Perlane® Injectable Gels | Medicis Pharmaceutical Corporation Scottsdale , AZ 85258 |
Change in cleaning procedure in conjunction with the manufacturing of the device. |
| P040024/S035 3/5/09 |
Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale , AZ 85258 |
Changes as follows: 1) add a new raw material supplier; 2) change the site for raw material quality assurance testing to Q-Med AB; 3) add a heavy metals test for raw materials; and 4) modify a test method for the quality control of the finished product. |
| P040037/S017 3/20/09 |
Gore Viabahn® Endoprosthesis | W.L. Gore & Associated, Inc. Flagstaff , AZ 86001 |
Changes to the packaging component for the device. |
| P040047/S014 3/6/09 |
Coaptite® Injectable Implant | BioForm Medical, Inc. Franksville , WI 53126 |
Change in the mixing operation for the device. |
| P050009/S007 3/13/09 |
C 2a-Taper™ Acetabular System | Biomet, Inc. Warsaw , IN 46581 |
Use of an optional cleaning process for the C 2a-Taper™ Acetabular System screws. |
| P050020/S009 3/6/09 |
FreeStyle Navigator® Continuous Glucose Monitoring System | Abbott Laboratories Alameda , CA 94502 |
Changes to the clean room environmental monitoring program currently described in DOC04098 for the device. |
| P050037/S020 3/6/09 |
Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville , WI 53126 |
Change in the mixing operation for the device. |
| P050052/S022 3/6/09 |
Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville , WI 53126 |
Change in the mixing operation for the device. |
| P060002/S004 3/3/09 |
FLAIR Endovascular Stent Graft | Bard Peripheral Vascular, Inc. Tempe , AZ 85280 |
Movement of a manufacturing process within the Bard campus. |
| P060003/S004 3/5/09 |
Abbott AxSYM AUSAB | Abbott Laboratories, Inc. Abbott park, IL 60064 |
Addition of a new quality control testing procedure to evaluate the suitability of recalcified nonreactive plasma used in anti-HBs positive components. |
| P060033/S032 3/4/09 |
Endeavor Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa , CA 95403 |
Change to update the Metallographic test method. |
| P060038/S003 3/25/09 |
Mitroflow Aortic Pericardial Heart Valve | CarboMedics, Inc. Arvada , CO 80004 |
Implementation of an automated parts washer for the device. |
| P070007/S006 3/9/09 |
Talent Thoracic (TAA) Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rosa , CA 95403 |
Change from a manual to an automated process for cutting and sealing the graft material. |
| P070007/S007 3/16/09 |
Medtronic Vascular Talent Thoracic Stent Graft System | Medtronic Vascular Santa Rosa , CA 95403 |
Temporary rework of the Talent Abdominal and Talent Thoracic Stent Graft Systems for the CoilTrac Delivery system to the Xcelerant Delivery System. |
| P070015/S012 3/2/09 |
XIENCE V™ Everolimus-Eluting Coronary Stent System | Abbott Vascular, Inc. Santa Clara , CA 95054 |
Modification to cyclohexanone test methods. |
| P070015/S13 3/16/09 |
XIENCE V™ and Promus™ Everolimus-Eluting Coronary Stent System | Abbott Vascular, Inc. Temecula , CA 92591 |
Increase of the relative humidity specification in the clean room. |
| P070027/S007 3/9/09 |
Talent Abdominal (AAA) Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rosa , CA 95403 |
Change from a manual to an automated process for cutting and sealing the graft material. |
| P070027/S008 3/16/09 |
Medtronic Vascular Talent Abdominal Stent Graft System | Medtronic Vascular Santa Rosa , CA 95403 |
Temporary rework of the Talent Abdominal and Talent Thoracic Stent Graft Systems for the CoilTrac Delivery system to the Xcelerant Delivery System. |
| P080011/S001 3/25/09 |
BIOFINITY® (comfilcon A) Soft Contact Lens for Extended Wear | CooperVision, Inc. Norfolk , VA 23507 |
Addition of two alternate qualified suppliers of a raw material used in the manufacturing of comfilcon A lenses. |
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 74
Summary of PMA Originals Under Review
Total Under Review: 70
Total Active: 30
Total On Hold: 40
Number Greater Than 180 Days:
Summary of PMA Supplements Under Review
Total Under Review: 533
Total Active: 365
Total On Hold: 168
Number Greater Than 180 Days: 23
Summary of All PMA Submissions Received
Originals: 1
Supplements: 164
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 74
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 169.4
FDA Time: 124.9 Days MFR Time: 44.5 Days
Updated May 1, 2009
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
