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.
| P050018 1/8/07 |
AngioSculpt® Scoring Balloon Catheter | AngioScore, Inc. Fremont , CA 94538 |
Approval for the AngioSculpt® Scoring Balloon Catheter. The device is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion. |
| P060001 1/24/07 |
Protégé® GPS™ and Protégé® RX Carotid Stent Systems | ev3, Inc. Plymouth , MN 55442 |
Approval for the Protégé® GPS™ and Protégé® RX Carotid Stent Systems. This device is indicated for used in conjunction with ev3 embolic protection devices, are indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet the following criteria: 1) patients with carotid artery stenosis ( ³ 50% for symptomatic patients by ultrasound or angiography or ³ 80% for asymptomatic patients by ultrasound or angiography) of the common or internal carotid artery, and 2) patients must have a reference vessel diameter within the range of 4.5 mm and 9.5 mm at the target lesion. |
| P860057/S036 1/8/07 180-Day |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis, Models 2700, 2700FX, 2800, 2800TFX; Carpentier-Edwards® PERIMOUNT Magna® Pericardial Bioprosthesis, Models 3000, 3000TFX; and Carpentier-Edwards® PERIMOUNT Plus® Pericardial Bioprosthesis, Models 6900P and 6900PTFX | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval to decrease the minimum leaflet tissue thickness specification for the 25mm and 27mm valves. |
| P860057/S038 1/29/07 135-Day |
Carpentier-Edwards Perimount Pericardial Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for an additional supplier of twist polytetrafluoroeth-ylene (PTFE) sewing thread. |
| P860057/S039 1/18/07 Real-Time |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis, Models 2700, 2700FX, 2800, 2800TFX; Carpentier-Edwards® PERIMOUNT Magna® Pericardial Bioprosthesis, Models 3000, 3000TFX; and Carpentier-Edwards® PERIMOUNT Plus® Pericardial Bioprosthesis, Models 6900P and 6900PTFX | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for changing the number of turns per meter to the sewing thread. |
| P870038/S009 1/29/07 135-Day |
Starr-Edwards Silastic Ball Heart Valve Prosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for an additional supplier of twist polytetrafluoroeth-ylene (PTFE) sewing thread. |
| P870038/S010 1/18/07 Real-Time |
Starr-Edwards™ Silastic Ball Heart Valve Prosthesis Models 1260 and 6120 | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for changing the number of turns per meter to the sewing thread. |
| P870038/S011 1/19/07 Real-Time |
Starr-Edwards™ Silastic Ball Heart Valve Prosthesis Models 1260 and 6120 | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for a minor design change and change in material supplier. |
| P870056/S024 1/29/07 135-Day |
Carpentier-Edwards Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for an additional supplier of twist polytetrafluoroeth-ylene (PTFE) sewing thread. |
| P870056/S025 1/18/07 Real-Time |
Carpentier-Edwards® Bioprosthesis, Models 2625, 6625, Valved Conduit Model 4300 | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for changing the number of turns per meter to the sewing thread. |
| P870077/S022 1/29/07 135-Day |
Carpentier-Edwards Duraflex Low Pressure Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for an additional supplier of twist polytetrafluoroeth-ylene (PTFE) sewing thread. |
| P870077/S023 1/18/07 Real-Time |
Carpentier-Edwards® Duraflex® Low Pressure Bioprosthesis, Models 6625LP and 6625ESR-LP | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for changing the number of turns per meter to the sewing thread. |
| P890003/S115 1/30/07 Real-Time |
Medtronic Models 2490G (Rev. T Application Software Version 5V3); Medtronic 2020A CardioSight Reader (Application Software Version 5V3); and Medtronic 2491 DDMA Software | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Medtronic Models 2490G (Rev. T Application Software Version 5V3); Medtronic 2020A CardioSight Reader (Application Software Version 5V3); and Medtronic 2491 DDMA Software. The Medtronic 2491 DDMA software contains the XML Translation Utility (XMLTU) software version V17, the presenting Waveform Utility (PWF) software version 16V1, and the Session Data Decode (SDD) software version 1V2. |
| P950037/S047 1/30/07 Real-Time |
Programmer Software B-KT0.0.A/1 and B-K00.T.U/1 |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for minor changes to the RF circuitry in the Lexos and Lumos families of implantable cardioverter defibrillators and approval for updated software versions to correct bradycardia and tachycardia software anomalies. |
| D970012/S030 1/31/07 135-Day |
Inflatable Penile Prosthesis Model 700 | American Medical Systems Minnetonka, MN 55343 |
Approval for lowering the molding temperature when producing components for the device. |
| P980016/S082 1/24/07 135-Day |
Marquis DR, Marquis VR, Maximo DR, Maximo VR, Intrinsic 30, Intrinsic, Entrust 30J/35J, Virtuoso | Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change in the allowable exposure limit for the battery and capacitor at the final device manufacturing site. |
| P980023/S026 1/30/07 Real-Time |
Programmer Software A-K00.1.U/6; Lexos VR, Lexos VR-T, Lumos VR-T |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for minor changes to the RF circuitry in the Lexos and Lumos families of implantable cardioverter defibrillators and approval for updated software versions to correct bradycardia and tachycardia software anomalies. |
| P980023/S027 1/26/07 Real-Time |
Linox S and Linox T ICD Leads |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for leads based on the Linox SD and Linox TD leads with one shock coil instead of two shock coils. The devices, as modified, will be marketed under the trade names Linox S Implantable Cardioverter Defibrillator (ICD) Lead and Linox T Implantable Cardioverter Defibrillator Lead and are indicated for use in conjunction with a Biotronik ICD. Currently, data is not available regarding the use of these lead systems with ICDs of other manufacturers. Use of other ICDs may adversely affect sensing and/or therapy delivery. |
| P980025/S001 1/12/07 180-Day |
Logicon Caries Detector | GA Industries Rancho Palos Verdes, CA 90275 |
Approval for a manufacturing site located at GA Industries, Rancho Palos Verdes, California. |
| P980035/S060 1/24/07 135-Day |
EnRhythm Family of Devices | Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change in the allowable exposure limit for the battery and capacitor at the final device manufacturing site. |
| P980035/S071 1/30/07 Real-Time |
Medtronic Models 2490G (Rev. T Application Software Version 5V3); Medtronic 2020A CardioSight Reader (Application Software Version 5V3); and Medtronic 2491 DDMA Software | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Medtronic Models 2490G (Rev. T Application Software Version 5V3); Medtronic 2020A CardioSight Reader (Application Software Version 5V3); and Medtronic 2491 DDMA Software. The Medtronic 2491 DDMA software contains the XML Translation Utility (XMLTU) software version V17, the presenting Waveform Utility (PWF) software version 16V1, and the Session Data Decode (SDD) software version 1V2. |
| P980037/S013 1/10/07 Real-Time |
AngioJet™ Rheolytic Thrombectomy System – AngioJet XMI-RX+ Catheter | Possis Medical, Inc. Minneapolis, MN 55433 |
Approval for AngioJet XMI-RX+ Catheter. |
| P980037/S017 1/25/07 Real-Time |
Possis AngioJet® Rheolytic™ Thrombectomy System – Spiroflex® Catheter | Possis Medical, Inc. Minneapolis, MN 55433 |
Approval for changes to the XMI-RX Catheter resulting in a new catheter called Spiroflex. |
| P980040/S007 1/4/07 180-Day |
TECNIS™ Foldable Acrylic Posterior Chamber Intraocular Lens (IOL), Model AR40xEM | Advanced Medical optics, Inc. Santa Ana, CA 92795 |
Approval to market Model AR40xEM intraocular lens (IOL) under the TECNIS™ trade name and for the following labeling claims: 1) Improved mesopic contrast sensitivity; 2) Improved mesopic low-contrast acuity; and 3) reduced spherical aberration. |
| P990066/S026 1/3/07 Special |
Senographe DS and Essential Systems | GE HealthCare Waukesha, WI 53188 |
Approval for modifications to the labeling regarding the placement of the laterality and view marker that FDA approved under P990066/S022. |
| P990081/S003 1/11/07 180-Day |
PATHWAY® anti-HER-2/Neu (4B5) Primary Antibody | Ventana Medical System, Inc. Tucson, AZ 85755 |
Approval for modifications to the PATHWAY® c-erbB-2 Primary Antibody(clone CB11) which include 1) change the primary antibody from the mouse monoclonal antibody CB11 to the rabbit monoclonal antibody 4B5, 2) change the detection format from Basic DAB Detection Kit to the Ventana Medical Systems iVIEW DAB Detection Kit, 3) add the optional ultraView universal DAB Detection Kit for biotin free detection format, 4) consolidate level 1,3 and negative HER-2 assay control slides onto a single slide and add a level 2 assay control and the control will be marketed under the trade name of PATHWAY HER2 4 in 1 Control Slide, and 5) include the Ventana Image Analysis System (VIAS) in the labeling. The device, as modified, will be marketed under the trade name PATHWAY® Anti-HER-2/Neu (4B5) Primary Antibody and is indicated for: Ventana Medical Systems, Inc.’s (Ventana) PATHWAY® anti-HER-2/neu (4B5) Primary Antibody (PATHWAY HER2 (4B5)) is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a Ventana automated immunohistochemistry slide staining device. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is being considered. |
| P000007/S011 1/29/07 135-Day |
Edwards Prima Plus Stentless Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for an additional supplier of twist polytetrafluoroeth-ylene (PTFE) sewing thread. |
| P000007/S012 1/18/07 Real-Time |
Edwards Prima Plus® Stentless Bioprosthesis Model 2500P | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for changing the number of turns per meter to the sewing thread. |
| P000009/S021 1/30/07 Real-Time |
Programmer Software A-K00.1.U/6; Lexos DR, Lexos DR-T, Lumos DR-T |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for minor changes to the RF circuitry in the Lexos and Lumos families of implantable cardioverter defibrillators and approval for updated software versions to correct bradycardia and tachycardia software anomalies. |
| P000039/S020 1/30/07 Real-Time |
AMPLATZER Septal Occluder and AMPLATZER Duct Occluder | AGA Medical Corporation Golden Valley, MN 55427 |
Approval for modifications to the device packaging and inclusion of a three year shelf life for the original AMPLATZER Duct Occluder and Septal Occluder Delivery and Exchange Systems. |
| P010012/S102 1/26/07 180-Day |
CONTAK RENEWAL RF Pulse Generator | Guidant Corp. St. Paul, MN 55112 |
Approval for a manufacturing site located at Guidant Ireland, Tipperary, Ireland. |
| P010025/S009 1/17/07 Real-Time |
Selenia Full Field Digital Mammography System | Hologic, Inc. Danbury, CT 06810 |
Approval for mounting Hologic SecurView reference image viewer into the Selenia Acquisition Workstation (AWS) cabinet for retrieving and displaying patient’s prior images but not for primary image diagnosis. |
| P010031/S049 1/24/07 135-Day |
InSync Marquis, InSync II Marquis, InSync Sentry, InSync III Marquis, InSync II Protect, InSync Maximo, Concerto | Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change in the allowable exposure limit for the battery and capacitor at the final device manufacturing site. |
| P010031/S061 1/30/07 Real-Time |
Medtronic Models 2490G (Rev. T Application Software Version 5V3); Medtronic 2020A CardioSight Reader (Application Software Version 5V3); and Medtronic 2491 DDMA Software | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Medtronic Models 2490G (Rev. T Application Software Version 5V3); Medtronic 2020A CardioSight Reader (Application Software Version 5V3); and Medtronic 2491 DDMA Software. The Medtronic 2491 DDMA software contains the XML Translation Utility (XMLTU) software version V17, the presenting Waveform Utility (PWF) software version 16V1, and the Session Data Decode (SDD) software version 1V2. |
| P010041/S011 1/29/07 135-Day |
Carpentier-Edwards S.A.V. Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for an additional supplier of twist polytetrafluoroeth-ylene (PTFE) sewing thread. |
| P010041/S012 1/18/07 Real-Time |
Carpentier-Edwards® Supraannular (S.A.V.®) Bioprosthesis Model 2650 and 6650 | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for changing the number of turns per meter to the sewing thread. |
| P020024/S014 1/30/07 Real-Time |
AMPLATZER Septal Occluder and AMPLATZER Duct Occluder | AGA Medical Corporation Golden Valley, MN 55427 |
Approval for modifications to the device packaging and inclusion of a three year shelf life for the original AMPLATZER Duct Occluder and Septal Occluder Delivery and Exchange Systems. |
| P020026/S030 1/10/07 180-Day |
CYPHER Sirolimus-eluting Coronary Stents on RAPTOR Over-the-Wire Delivery System | Cordis Corporation Miami, FL 33102 |
Approval for a process enhancer for an adhesive used in construction of the delivery system. |
| P040012/S020 1/5/07 135-Day |
RX ACCULINK® and ACCULINK® Carotid Stent Systems | Abbott Vascular – Vascular Solutions Santa Clara, CA 95052 |
Approval for a change in the cleaning methods to remove manufacturing materials in RX ACCULINK® and ACCULINK® Carotid Stents. |
| P040014/S004 1/10/07 180-Day |
Therapy Ablation Catheter and IBI-1500T Cardiac Ablation Generator | Irvine Biomedical, Inc. Irvine, CA 92614 |
Approval for 1) the addition of thermistor temperature sensor catheters to the Therapy catheter model mix, 2) the addition of a 1763-E compatible interface cable to the 4mm Thermistor Ablation Catheter, and 3) the addition of the 1778-E compatible interface cable to the 8mm Thermistor Ablation Catheter. |
| P040020/S003 1/30/07 Real-Time |
AcrySof® ReSTOR® Apodized Diffractive Aspheric IOL Models SN6AD3 and MN6AD3 | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for the addition of a prolate surface to the anterior optic, changing the optic shape factor to be more equiconvex, and the use of Natural material. |
| P040038/S008 1/19/07 Real-Time |
Xact® Carotid Stent System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Approval for modifications to the processes and components used to manufacture the stent delivery system handle. |
| P040042/S006 1/10/07 180-Day |
Therapy Dual 8 Catheter and IBI-1500T6 Cardiac Ablation Generator | Irvine Biomedical, Inc. Irvine, CA 92614 |
Approval for 1) the addition of thermistor temperature sensor catheters to the Therapy catheter model mix, 2) the addition of a 1763-E compatible interface cable to the 4mm Thermistor Ablation Catheter, and 3) the addition of the 1778-E compatible interface cable to the 8mm Thermistor Ablation Catheter. |
| P050007/S002 1/16/07 Special |
StarClose™ Vascular Closure System, Model 1004, Version 2.10 | Abbott Vascular Devices Redwood City, CA 94063 |
Approval for changes in the labeling for the device. |
| P050044/S001 1/25/07 180-Day |
Vitagel Surgical Hemostat | Orthovita, Inc. Malvern, PA 19355 |
Approval for revised CellPaker manufacture by Special Team Medical Services (Yorba Linda, California), terminal sterilization of the CellPaker by Sterigenics US, Inc. (San Diego, California), and change in contractor performing the Limulus Amebocyte Lysate assay to LexaMed, LTD (Toledo, Ohio). |
30-Day Notices (135 Day Supplement was not required)
| P790018/S047 1/24/07 |
Medtronic Hall™ Rotatable Aortic Valved Collagen Impregnated Conduit | Medtronic Cardiac Surgery Minneapolis, MN 55432 |
Use of an alternate conduit component for the Medtronic Hall Conduit. |
| P810006/S026 1/9/07 |
CollaStat Absorbable Collagen Hemostatic Agents | Integra Plainsboro, NJ 08536 |
Change in manufacturing process for a QC release test for finished devices used in the collagen purification process. |
| P850010/S023 1/9/07 |
Helistat Absorbable Collagen Hemostatic Agents | Integra Plainsboro, NJ 08536 |
Change in manufacturing process for a QC release test for finished devices used in the collagen purification process. |
| P910023/S129 1/11/07 |
St. Jude Medical ICDs and CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Use of an automated hydrohone cleaning machine in ICD and CRT-D production. |
| P910023/S130 1/19/07 |
Cadence Family of Implantable Cardioverter Defibrillators (ICDs) | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Modifications to the automated test software used for component/ subassembly and device level testing. |
| P980016/S093 1/11/07 |
Virtuoso ICD | Medtronic, Inc. Shoreview, MN 55126 |
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data. |
| P980035/S070 1/11/07 |
Kappa 700 IPG, Kappa 900 IPG, EnPulse IPG, Adapata/ Versa/ Sensia IPG | Medtronic, Inc. Shoreview, MN 55126 |
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data. |
| P980040/S09 1/16/07 |
AMO Sensar® Soft Acrylic UV-Light Absorbing Posterior Chamber IOL | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change to a fixture used in the sheet casting process for the foldable and soft acrylic intraocular lenses. |
| P980040/S010 1/16/07 |
AMO Sensar® Soft Acrylic UV-Light Absorbing Posterior Chamber IOL | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Use of new equipment in the manufacture of the soft acrylic intraocular lenses. |
| P990020/S023 1/18/07 |
Medtronic Vascular AneuRx Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Addition of an alternate supplier of stent graft components. |
| P990041/S009 1/19/07 |
DiaSorin ETI-AB-EBK PLUS | DiaSorin, Inc, Stillwater, MN 55082 |
Change in the manufacturing of a raw material. |
| P990043/S010 1/19/07 |
DiaSorin ETI- EBK PLUS | DiaSorin, Inc, Stillwater, MN 55082 |
Change in the manufacturing of a raw material. |
| P990044/S008 1/19/07 |
DiaSorin ETI-CORE-IGMK PLUS | DiaSorin, Inc, Stillwater, MN 55082 |
Change in the manufacturing of a raw material. |
| P990056/S006 1/19/07 |
Elecsys Total PSA CalSet | Roche Diagnostics Indianapolis, IN 46250 |
Change in the labeling in the precautions and warnings section, concerning the testing of potentially infectious human-derived material used in the assay. |
| P990080/S013 1/16/07 |
Array® Multifocal Intraocular Lenses Foldable Ultraviolet Light-Absorbing Posterior Chamber IOL, CeeOn Models 911A and 913A & Tecnis Models Z9000 and Z9001 |
Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Alternate supplier (ACROS Organics) for one of the components of the silicone raw materials, octaphenyltetra-methyloxane. |
| P990080/S014 1/16/07 |
Foldable Ultraviolet Light-Absorbing Posterior Chamber IOL, CeeOn Models 911A and 913A & Tecnis Models Z9000 and Z9001 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Implementation of a sample Modulation Transfer function inspection for lens model ZA9003. |
| P990080/S015 1/16/07 |
Foldable Ultraviolet Light-Absorbing Posterior Chamber IOL, CeeOn Models 911A and 913A & Tecnis Models Z9000 and Z9001 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change to a fixture used in the sheet casting process for the foldable and soft acrylic intraocular lenses. |
| P990080/S016 1/16/07 |
Foldable Ultraviolet Light-Absorbing Posterior Chamber IOL, CeeOn Models 911A and 913A & Tecnis Models Z9000 and Z9001 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Use of new equipment in the manufacture of the soft acrylic intraocular lenses. |
| P990080/S017 1/16/07 |
Foldable Ultraviolet Light-Absorbing Posterior Chamber IOL, CeeOn Models 911A and 913A & Tecnis Models Z9000 and Z9001 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change of existing belt sealers to a newer model. |
| P990080/S018 1/16/07 |
Foldable Ultraviolet Light-Absorbing Posterior Chamber IOL, CeeOn Models 911A and 913A & Tecnis Models Z9000 and Z9001 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the purification step for one of the components of the silicone raw materials. |
| P000021/S009 1/4/07 |
Dimension® TPSA Flex® Reagent Cartridge | Dade Behring, Inc. Newark, DE 19714 |
Change to revise the cuvette film manufacturing process. |
| P000027/S004 1/19/07 |
Elecsys Free PSA CalSet and Elecsys Free PSA CalCheck |
Roche Diagnostics Indianapolis, IN 46250 |
Change in the labeling in the precautions and warnings section, concerning the testing of potentially infectious human-derived material used in the assay. |
| P010031/S060 1/11/07 |
InSync ICD | Medtronic, Inc. Shoreview, MN 55126 |
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data. |
| P020004/S018 1/5/07 |
GORE EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change in the Ethylene Oxide (EO) sterilization cycle for the device. |
| P020027/S005 1/4/07 |
Dimension® FPSA Flex® Reagent Cartridge | Dade Behring, Inc. Newark, DE 19714 |
Change to revise the cuvette film manufacturing process. |
| P030054/S047 1/11/07 |
St. Jude Medical ICDs and CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Use of an automated hydrohone cleaning machine in ICD and CRT-D production. |
| P030054/S048 1/19/07 |
EPIC HF Family of Cardiovascular Resynchronization Therapy Devices (CRT-Ds) | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Modifications to the automated test software used for component/ subassembly and device level testing. |
| P040002/S008 1/18/07 |
Powerlink System with Visiflex Delivery Catheter | Endologix, Inc. Irvine, CA 92618 |
Adding an additional non-destructive load test. |
| P040012/S025 1/18/07 |
RX Acculink® and ACCULINK® Carotid Stent Systems | Abbott Vascular Santa Clara, CA 95054 |
Change to the final visual inspection process. |
| P040038/S009 1/25/07 |
Xact Carotid Stent System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Revision of the sterilization load configuration for the Carotid Stent Systems, and introduction of a system for the control of mandrels. |
| P040043/S012 1/5/07 |
GORE TAG® Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change in the Ethylene Oxide (EO) sterilization cycle. |
| P050012/S006 1/23/07 |
DexCom STS System | DexCom, Inc. San Diego, CA 92121 |
Revised final release manufacturing software and test procedure to improve process controls, and Proposed Final Release criteria modification for the STS Sensor. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 42
Summary of PMA Originals Under Review
Total Under Review: 82
Total Active: 41
Total On Hold: 41
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 421
Total Active: 201
Total On Hold: 220
Number Greater Than 180 Days: 13
Summary of All PMA Submissions Received
Originals: 5
Supplements: 66
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 42
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 156.9
FDA Time: 127.2 Days MFR Time: 29.6 Days
Updated February 12, 2007
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