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.
P050045 |
Dako TOP2A FISH pharmDx™ Kit |
Dako Denmark A/S Glostrup , Denmark DK-2600 |
Approval for the TOP2A FISH pharmDx™ Kit. The device is indicated for: TOP2A FISH pharmDx™ Kit is designed to detect amplifications and deletions of the TOP2A gene using fluorescence in situ hybridization (FISH) technique on formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Deletions and amplifications of the TOP2A gene serve as a marker for poor prognosis in high-risk breast cancer patients. Results from the TOP2A FISH pharmDx™ Kit are intended for use as an adjunct to existing clinical and pathological information. |
P790002/S025 1/17/08 |
Biomet® BHS-Mini
|
Biomet Manufacturing Corporation Warsaw , IN |
Approval for design modifications related to two new coils, a new battery type, a new coil application method, and a redesigned control box. The device, as modified, will be marketed under the trade name Biomet® BHS-Mini and is indicated for the treatment of fracture non-unions, failed fusions, and congenital pseudoarthrosis in the appendicular system. |
P840001/S097 |
RestoreULTRA™ Rechargeable Neurostimulation System |
Medtronic Neurological Minneapolis , MN 55432 |
Approval for the RestoreULTRA™ Rechargeable Neurostimulation System. The device is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following: 1) Failed Back Syndrome or Low Back Syndrome or Failed Back; 2) Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed Back syndrome; 3) post laminectomy pain; 4) unsuccessful disk surgery; 5) Degenerative Disk Disease (DDD)/Herniated Disk pain refractory to conservative and surgical interventions; 6) peripheral causalgia; 7) epidural fibrosis; 8) arachnoiditis or lumbar adhesive arachnoiditis; 9) Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or causalgia; and 10) multiple back surgeries. |
P840001/S099 |
Itrel 3, Synergy, Restore Prime, and Prime Advanced Family of Implantable Pulse Generators or Implantable Neurostimulators |
Medtronic Neuromodulation Minneapolis MN 55432 |
Approval for changing the surfactant used to help disperse polytetrafluoroethylene (PTFE) during the battery manufacturing process. |
P860004/S093 1/11/08 |
SynchroMed II Pump |
Medtronic Neuromodulation Minneapolis MN 55432 |
Approval for changing the surfactant used to help disperse polytetrafluoroethylene (PTFE) during the battery manufacturing process. |
P870072/S039 1/31/08 |
Thoratec Implantation Ventricular Assist Device (IVAD) System |
Thoratec Corporation Pleasanton , CA |
Approval to revise the IVAD Instructions for Use to delete the reference to paracorporeal placement of the IVAD and indicate that the IVAD should be contraindicated for the paracorporeal placement. |
P900030/S010 1/11/08 |
Contigen® Bard® Collagen Implant |
Allergan |
Approval for updated Directions for Use in order to strengthen information on adverse events. |
P910077/S083 1/30/08 |
Latitude™ Communicator Software & System Software |
Boston Scientific Corporation |
Approval for the Latitude Communicator Software (Model 6482) version 2.1 and related System Software (Model 6488) that contains Regulated Application Server (RAS) software version 2.40 as well as associated labeling and operator manual updates. The software modifications are intended to support new device models (LIVIAN), make minor software corrections, and improve ease of use with the Latitude system. |
P920048/S005 1/29/08 |
FullTerm Fetal Fibronectin Test TLi IQ System Analyzer (TLi) Component |
Cytyc Corporation Sunnyvale , CA 94089 |
Approval for a manufacturing site located at Cytyc Corp., Marlborough, Massachusetts. |
P930016/S030 |
STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS™) WaveScan WaveFront® System |
VISX, Inc. a subsidiary of Advanced Medical Optics |
Approval for the upgrade WaveScan WaveFront System Software Version 3.90. The device, as modified, will be marketed under the trade names STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS™) WaveScan WaveFront® System and are indicated for wavefront-guided (WRG) laser assisted in situ keratomileusis (LASIK) to achieve eye of presbyopic myopes: 1) 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision; 2) with myopic astigmatism up to -6.00 D MRSE, with cylinder up to -3.00 D, and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; 3) with documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and 4) with a successful preoperative trial of monovision or history of monovision experience. |
P940040/S008 |
AMPLICOR Mycobacterium Tuberculosis (MTB) Test |
Roche Molecular Systems, Inc. |
Approval for a manufacturing site located at Roche Molecular Systems, Inc., Pleasanton, California for bulk positive control stock manufacturing. |
P950022/S049 1/10/08 |
Durata™ Lead Family |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for a tradename change from RIATA® STS Optim® to Durata™ for Lead Models 7120, 7121, 7122, 7130, 7131, 7170 and 7171. |
P950027/S010 |
Hyalgan |
Fidia Farmaceutici, S.p.A. |
Approval for the following changes in the label: 1) the addition of the trade name, Hyalectin®, for sodium hyaluronate in the device description; and 2) modifications to the Contraindications, Warnings and Precautions to enhance the appropriate usage of the device. |
P960009/S043 1/11/08 |
Kinetra and Soletra Family of Neurostimulators |
Medtronic Neuromodulation Minneapolis MN 55432 |
Approval for changing the surfactant used to help disperse polytetrafluoroethylene (PTFE) during the battery manufacturing process. |
P960040/S156 1/30/08 |
Prizm and Vitality ICD Families |
Boston Scientific Corporation |
Approval for the Latitude Communicator Software (Model 6482) version 2.1 and related System Software (Model 6488) that contains Regulated Application Server (RAS) software version 2.40 as well as associated labeling and operator manual updates. The software modifications are intended to support new device models (LIVIAN), make minor software corrections, and improve ease of use with the Latitude system. |
P970004/S042 |
Interstim Family of Neurostimulators |
Medtronic Neuromodulation |
Approval for changing the surfactant used to help disperse polytetrafluoroethylene (PTFE) during the battery manufacturing process. |
P970021/S016 1/29/08 |
Gynecare Thermochoice III Uterine Balloon Therapy System |
Ethicon |
Approval of the post-approval study. |
P980016/S118 |
Virtuoso ICD’s: Models D154AWG, D154VWC |
Medtronic, Inc. |
Approval for minor design changes that add alternate components – diodes (XD433, XD445) and capacitor (AVX Kyocera X5R) – to the approved device components for use on the hybrid as well as minor associated modifications to the substrate. The design modifications are intended to increase supply line robustness, reduce component costs, and improve incoming component quality. |
P980022/S020 1/22/08 |
CGMS® iPro™ System |
Medtronic MiniMed, Inc. |
Approval for the CGMS iPro System. The CGMS iPro System includes the CGMS iPro digital recorder, Solutions Software for CGMS iPro, ComLink iPro, and CGMS iPro wand. The device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. The information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring device. The information collected by the CGMS iPro Digital Recorder may be downloaded, using the ComLink iPro, the Solutions Software for CGMS iPro and a personal computer, and reviewed by healthcare professionals. The information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions. |
P980049/S021 1/15/08 |
Isoline 2CR Defibrillation Leads Models 2CR5, 2CR6 and 2CR7 |
ELA Medical, Inc. Plymouth , MN 55441 |
Approval for: 1) modifications to the Swift 1CT series ICD lead to create a dual-coil, integrated bipolar, active-fixation ICD lead. The new lead will be marketed under the name Isoline 2CR and is indicated for use with ELA Medical implantable defibrillators; 2) manufacturing site at Sorin Biomedica CRM SRL, Saluggia, Italy and two sterilization sites at Bioster SPA, Bergamo, Italy. |
P980049/S024 1/9/08 |
Isoline 2CT5 & 2CT6 Defibrillation Leads |
ELA Medical, Inc. Plymouth , MN 55441 |
Approval for the Isoline 2CT Defibrillation Leads. The device, as modified, will be marketed under the trade name Isoline 2CT5 & 2CT6 transvenous defibrillation leads and is indicated to provide right ventricular pacing, sensing and defibrillation when used as part of an ELA Medical implantable defibrillator. |
P990013/S014 1/25/08 |
Collamer™ Ultraviolet Absorbing Posterior Chamber Intraocular Lens |
STAAR Surgical Co. |
Approval for parametric lot release using existing validated steam sterilization cycles. The device, as modified, will be marketed under the trade name Collamer™ Ultraviolet-Absorbing Posterior Chamber Intraocular Lens and is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsification cataract extraction. The lens is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy). |
P990020/S029 1/4/08 |
Medtronic Vascular AneuRx AAAdvantage Stent Graft with Xcelerant Delivery System |
Medtronic Vascular Santa Rose , CA 95403 |
Approval for a change to the primary packaging for the Xcelerant Delivery System for the AneuRx AAAdvantage Stent Graft. |
P990033/S015 1/11/08 |
PEPGEN 15 |
Dentsply Int’l |
Approval for a contract sterilization site located at Sterigenics US, Inc, Gurnee, Illinois. |
P990065/S004 1/18/08 |
SIR-Spheres |
Sirtex Medical Ltd. Lane Cove, Australia |
Approval for a manufacturing and sterilization site located in Wilmington, Massachusetts. |
P000010/S011 |
AMPLICPR Hepatitis C Virus (HCV) Test Version 2.0 |
Roche Molecular Systems, Inc. Pleasanton , CA 94566 |
Approval for a manufacturing site located at Roche Molecular Systems, Inc., Pleasanton, California for bulk positive control stock manufacturing. |
P000012/S015 1/11/08 |
COBAS AMPLICPR HCV Test Version 2.0 |
Roche Molecular Systems, Inc. Pleasanton , CA 94566 |
Approval for a manufacturing site located at Roche Molecular Systems, Inc., Pleasanton, California for bulk positive control stock manufacturing. |
P000049/S019 1/17/08 |
CardioSEAL® Septal Occlusion System with Qwik Load |
NMT Medical Boston , MA |
Approval to remove the Mullins Burst Test requirement for the device. |
P000054/S013 1/14/08 |
INFUSE® Bone Graft |
Medtronic Sofamor Danek |
Approval for the addition of a new validated cross-linking chamber. |
P000058/S025 1/14/08 |
INFUSE® Bone Graft/LT CAGE Lumbar Tapered Fusion Device |
Medtronic Sofamor Danek |
Approval for the addition of a new validated cross-linking chamber. |
P010012/S166 1/30/08 |
Renewal 3 RF Families |
Boston Scientific Corporation |
Approval for the Latitude Communicator Software (Model 6482) version 2.1 and related System Software (Model 6488) that contains Regulated Application Server (RAS) software version 2.40 as well as associated labeling and operator manual updates. The software modifications are intended to support new device models (LIVIAN), make minor software corrections, and improve ease of use with the Latitude system. |
P010031/S088 1/3/08 |
Concerto ICD’s: Models C154WK, C164AWK |
Medtronic, Inc. |
Approval for minor design changes that add alternate components – diodes (XD433, XD445) and capacitor (AVX Kyocera X5R) – to the approved device components for use on the hybrid as well as minor associated modifications to the substrate. The design modifications are intended to increase supply line robustness, reduce component costs, and improve incoming component quality. |
P030031/S005 |
NaviStar RMT ThermoCool Diagnostic/Ablation Deflectable Tip Catheters |
Biosense Webster, Inc. |
Approval for modifications to the NaviStar ThermoCool catheter design so that it is compatible with the Stereotaxis Niobe Magnetic Navigation System. |
P040036/S003 1/4/08 |
NaviStar RMT ThermoCool Diagnostic/Ablation Deflectable Tip Catheters |
Biosense Webster, Inc. |
Approval for modifications to the NaviStar ThermoCool catheter design so that it is compatible with the Stereotaxis Niobe Magnetic Navigation System. |
P040043/S016 1/11/08 |
GORE TAG™ Thoracic Endoprosthesis |
W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 |
Approval for the optional method of air striping to remove the wrapped graft from the mandrel. |
P040045/S003 |
VISTAKON (senofilcon A) Contact Lens, Clear and Visibility Tinted with UV Blocker |
Vistakon, Division of Johnson & Johnson Jacksonville , FL 32256 |
Approval for minor labeling changes. |
P050010/S001 |
ProDisc™-L Total Disc Replacement |
Synthes Spine Co., L.P. |
Approval for new polyethylene inlays with a tantalum radiographic marker embedded in the anterior lip of the inlay. |
P050033/S004 1/24/08 |
Elevess |
Anika Therapeutics, Inc. |
Approval for an increase in the Elevess expiration date from 9 to 18 months. |
P050037/S005 |
Radiesse® Injectable Implant |
BioForm Medical, Inc. |
Approval for the creation of a convenience kit and associated modifications to the labeling. |
P050038/S004 1/14/08 |
Arista AH Absorbable Hemostat |
Medafor, Inc. Minneapolis , MN 55430 |
Approval for a manufacturing site located at Enpath Medical, Inc., Minneapolis, Minnesota to perform filling, packaging, and labeling of the device. |
P050052/S006 1/25/08 Real-Time |
Radiesse® Injectable Implant |
BioForm Medical, Inc. Franksville , WI |
Approval for the creation of a convenience kit and associated modifications to the labeling. |
P050053/S004 1/14/08 |
INFUSE® Bone Graft |
Medtronic Sofamor Danek |
Approval for the addition of a new validated cross-linking chamber. |
30-Day Notices (135 Day Supplement was not required)
P840001/S105 1/17/08 |
Spinal Cord Stimulation |
Medtronic, Inc. Minneapolis , MN 55432 |
Use of an insert-molded process to manufacture the Bond Pad Array (BPA) in place of a press-fit manufacturing method. |
P840064/S034 1/4/08 |
Viscoat®, Duovisc® and DisCoVisc® Ophthalmic Viscosurgical Devices |
Alcon Research, LTD |
Additional aeration room located at Sterigenics in Belgium. |
P880091/S024 1/16/08 |
STAAR® Surgical Silicone UV-Absorbing Posterior Chamber Intraocular Lens |
STAAR® Surgical Monrovia , CA 91016 |
Removal of a post sterilization cosmetic lens inspection step. |
P890003/S133 1/4/08 |
Implantable Pulse Generators |
Medtronic, Inc. Mounds View, MN 55112 |
Minor changes to a welding procedure. |
P890047/S021 1/4/08 |
Provisc® Ophthalmic Viscosurgical Devices |
Alcon Research, LTD |
Additional aeration room located at Sterigenics in Belgium. |
P910023/S163 1/4/08 |
Cadence Family of ICDs |
St. Jude Medical Cardiac Rhythm Management division |
Alternate method and material used to attach components on the ICD/CRT-D. |
P910023/S164 1/11/08 |
Cadence Family of ICDs |
St. Jude Medical Cardiac Rhythm Management division |
Alternate supplier for the high voltage circuit board assembly. |
P910023/S165 1/17/08 |
Cadence Family of ICDs |
St. Jude Medical Cardiac Rhythm Management division |
Alternate supplier for several components. |
P910023/S166 1/24/08 |
Cadence ICDs |
St. Jude Medical Cardiac Rhythm Management division |
Changes to the Silver Vanadium Oxide (SVO) processing and electrolyte additive for batteries. |
P920004/S021 |
VasoSeal® Vascular Hemostasis Device |
Datascope Corporation Mahwah , NJ |
Change to the sponge plug rinse system from a semi-automated to a fully automated system. |
P960028/S026 1/23/08 |
3-Piece Soft Acrylic Intraocular Lenses (IOLs): Tecnis Acrylic IOLs, ReZoom Multifocal IOLs and Sensar Acrylic IOLs |
Advanced Medical Optics, Inc. |
Change in tumbling time for the 3-piece acrylic intraocular lenses. |
P960040/S157 1/25/08 |
Contak Renewal Family of Defibrillators |
Guidant Corporation |
Addition of a supplier for the thin film resistor chip component. |
P960040/S158 1/25/08 |
Vitality HE Family of Devices |
Guidant Corporation |
Processing of additional product on existing bonding machines. |
P970004/S047 1/17/08 |
InterStim® Therapy for Urinary Control |
Medtronic, Inc. Minneapolis , MN 55432 |
Use of an insert-molded process to manufacture the Bond Pad Array (BPA) in place of a press-fit manufacturing method. |
D970012/S047 1/17/08 |
AMS 700™ Penile Prosthesis |
American Medical Systems Minnetonka , MN 55343 |
Removal of a redundant component receiving inspection. |
P980016/S119 1/16/08 |
EnTrust, Virtuoso |
Medtronic, Inc. Mounds View, MN 55112 |
Changes in the manufacturing process for the Bond Pad Array (BPA) components from press-fit to insert-molded. |
P980022/S022 1/11/08 |
Continuous Glucose Monitoring System (CGMS) |
Medtronic MiniMed Northridge , CA 91325 |
Changes in the manufacturing process including replacement of centrifugation of glucose oxidase with filtration, and incorporation of keypad overlay with a new adhesive. |
P980035/S084 1/16/08 |
Concerto |
Medtronic, Inc. Mounds View, MN 55112 |
Changes in the manufacturing process for the Bond Pad Array (BPA) components from press-fit to insert-molded. |
P980040/S020 1/23/08 |
3-Piece Soft Acrylic Intraocular Lenses (IOLs): Tecnis Acrylic IOLs, ReZoom Multifocal IOLs and Sensar Acrylic IOLs |
Advanced Medical Optics, Inc. |
Change in tumbling time for the 3-piece acrylic intraocular lenses. |
P980053/S011 1/9/08 |
Durasphere Injectable Bulking Agent |
Carbon Medical Technologies, Inc. St. Paul , MN |
Change involving certain monitoring tests for the device. |
P990080/S029 1/23/08 |
3-Piece Soft Acrylic Intraocular Lenses (IOLs): Tecnis Acrylic IOLs, ReZoom Multifocal IOLs and Sensar Acrylic IOLs |
Advanced Medical Optics, Inc. Santa Ana , CA |
Change in tumbling time for the 3-piece acrylic intraocular lenses. |
P010012/S168 1/25/08 |
Contak Renewal Family of Defibrillators |
Guidant Corporation |
Addition of a supplier for the thin film resistor chip component. |
P010012/S169 1/25/08 |
Contak Renewal Family of Devices |
Guidant Corporation |
Processing of additional product on existing bonding machines. |
P010031/S089 1/16/08 |
EnRhythm |
Medtronic, Inc. Mounds View, MN 55112 |
Changes in the manufacturing process for the Bond Pad Array (BPA) components from press-fit to insert-molded. |
P020037/S002 1/11/08 |
FX miniRAIL® Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
Abbott Vascular, Inc. |
Change in a quality control test used to determine a specific attribute of the in process device. |
P030005/S049 1/17/08 |
CONTAK TR2 Cardiac Resynchronization Therapy Pacemaker (CRT-P) |
Guidant/ Boston Scientific Corporation |
Addition of two reflow ovens to the CONTAK TR2 hybrid solder reflow manufacturing process. |
P030025/S052 1/17/08 |
TAXUS™ Express 2™ Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Corp. |
Installation of an additional sterilization chamber at one of the current contract sterilization facilities. |
P030047/S010 1/16/08 |
Cordis PRECISE® RX Nitinol Stent System |
Cordis Corporation Warren , NJ |
Change in the manufacturing materials for the processing aid, which is used to tack the support member sleeve in place while the sleeve is heat-shrunk over the entire assembly. |
P030054/S075 1/4/08 |
Epic HF Family of CRT-Ds |
St. Jude Medical Cardiac Rhythm Management division |
Alternate method and material used to attach components on the ICD/CRT-D. |
P030054/S076 1/11/08 |
Epic HF Family of CRT-Ds |
St. Jude Medical Cardiac Rhythm Management division |
Alternate supplier for the high voltage circuit board assembly. |
P030054/S077 1/17/08 |
Epic HF Family of CRT-Ds |
St. Jude Medical Cardiac Rhythm Management division |
Alternate supplier for several components. |
P030054/S078 1/24/08 |
Epic HF Family of CRT-Ds |
St. Jude Medical Cardiac Rhythm Management division |
Changes to the Silver Vanadium Oxide (SVO) processing and electrolyte additive for batteries. |
P040016/S027 1/17/08 |
Liberté™ Coronary Stent System |
Boston Scientific Corp. |
Installation of an additional sterilization chamber at one of the current contract sterilization facilities. |
P040040/S002 1/25/08 |
Amplatzer® Muscular VSD Occluder |
AGA Medical Corporation |
Applicant to be the primary source for the laser welding process, while retaining the current vendor as a secondary source. |
P050007/S007 1/11/08 |
StarClose Vascular Closure System |
Abbott Vascular, Inc. |
Addition of a step to the manufacturing process to implement heat forming at the Pusher Body/ Obtruator Shaft Joint for the device. |
P050007/S008 1/17/08 |
StarClose Vascular Closure System |
Abbott Vascular, Inc. |
Alternate method of manufacturing of the StarClose clip used in the StarClose and StarClose SE Systems. |
P050012/S013 1/11/08 |
DexComSTS System |
DexCom, Inc. |
Addition of a supplier for the Dexcom sensor sub-assemblies. |
P060001/S004 1/30/08 |
Protégé GPS and Protégé RX Carotid Stent System |
eV3, Inc. |
Use of an alternate sterilization chamber for the above listed products. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 41
Summary of PMA Originals Under Review
Total Under Review: 74
Total Active: 27
Total On Hold: 47
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 427
Total Active: 262
Total On Hold: 165
Number Greater Than 180 Days: 13
Summary of All PMA Submissions Received
Originals: 4
Supplements: 101
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 41
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 152.2
FDA Time: 87.7 Days MFR Time: 64.5 Days
Updated July 15, 2008
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