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.
|
12/22/05 |
Visian ICL™ (Implantable Collamer Lens) |
STAAR Surgical Company Monrovia , CA 91016 |
Approval for the Visian ICL™ (Implantable Collamer Lens) Models MICL12.1, MICL12.6, MICL13.2 and MICL13.7. The device is indicated for adults 21-45 years of age: 1) to correct myopia ranging from -3.0 diopters to ≤-15.0 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; 2) to reduce myopia ranging from greater than -15.0 diopters to -20.0 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; and 3) with an anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopter for 1 year prior to implantation. |
|
12/20/05 |
VISTAKON® (senofilcon A) Contact Lens, Clear and Visibility Tinted with UV Blocker |
Vistakon, Division of Johnson & Johnson Vision Care, Inc. Jacksonville , FL 32247 |
Approval for the VISTAKON® (senofilcon A) Contact Lens, Clear and Visibility Tinted with UV Blocker. The device is indicated for use as follows: The VISTAKON® (senofilcon A) Soft Contact Lens (spherical) is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 1.00D or less of astigmatism. The VISTAKON® (senofilcon A) Multifocal Soft Contact Lens is indicated for the optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less. The VISTAKON® (senofilcon A) Toric Soft Contact Lens is indicated for the optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D of astigmatism or less. The VISTAKON® (senofilcon A) Multifocal-Toric Soft Contact Lens is indicated for the optical correction of distance and near in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less. The VISTAKON® (senofilcon A) UV Blocking Soft Contact Lens help protect against transmission of harmful UV radiation to the cornea and into the eye. Eye care professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear the lenses may be cleaned and disinfected using a chemical disinfection system only. VISTAKON® (senofilcon A) Contact Lenses may be prescribed for daily wear and extended wear for up to 6 nights/7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing eye care professional. |
|
12/21/05 |
StarClose™ Vascular Closure System |
Abbott Vascular Devices (AVD) Redwood City , CA 94063 |
Approval for the StarClose™ Vascular Closure System. The device is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis, ambulation, and dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5F or 6F procedural sheath. |
|
12/16/05 |
C 2 a-Taper™ Acetabular System |
Biomet Manufacturing Corporation Warsaw , IN 46581 |
Approval for the C 2 a-Taper™ Acetabular System. The device is indicated for use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and post-traumatic arthritis. |
|
12/20/05 |
Ceralas I Laser System and Ceralink™ Slit Lamp Adapter |
QLT USA, Inc. Fort Collins , CO 80525 |
Approval for the Ceralas I Laser System and Ceralink™ Slit Lamp Adapter. The device is indicated for the photoactivation of the light activated drug VISUDYNE (verteporfin for injection) in photodynamic therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis. |
P820003/S075 12/22/05 Real-Time |
Medtronic pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P830055/S093 12/12/05 Special |
LCS® Total Knee System |
DePuy Orthopaedics, Inc. Warsaw , IN 46581 |
Approval for changes in quality controls to various components of the LCS® Total Knee System. The changes include modifications to several Manufacturing Process Specifications (MPS) for Gamma Vacuum Foil (GVF) packaged products: 1) to add physical separation barriers to the sealing machine to prevent adjacent foil pouches from overlapping during the sealing operation, and 2) to require a second 100% inspection of the seal integrity of each package prior to shipment. |
P850051/S060 12/22/05 Real-Time |
Medtronic pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P860004/S075 12/23/05 Real-Time |
SynchroMed Implantable Infusion System |
Medtronic Neurological Minneapolis , MN 55432 |
Approval for a modified cleaning process of the platinum/iridium catheter tip of the Model 8731 catheter. |
P860019/S205 12/15/05 Real-Time |
PTCA Catheters |
Boston Scientific, Inc. Maple Grove , MN 55311 |
Approval for minor modifications to the Directions for Use Manuals (DFU) and labels for all affected PTCA Catheter Systems. |
P860057/S031 12/6/05 Special |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis, Models 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX, 6900, 6900P (PERIMOUNT Plus™) and 6900PTFX |
Edwards Lifesciences LLC Irvine , CA 92614 |
Approval for the addition of an inspection for the 3.8 oz jar used to package the bioprosthetic heart valves. |
P870056/S023 12/6/05 Special |
Carpentier-Edwards® Bioprosthesis, Models 2625 and 6625 |
Edwards Lifesciences LLC Irvine , CA 92614 |
Approval for the addition of an inspection for the 3.8 oz jar used to package the bioprosthetic heart valves. |
P870077/S021 12/6/05 Special |
Carpentier-Edwards® Duraflex® Low Pressure Bioprosthesis, Models 6625LP and 6625-ESR-LP |
Edwards Lifesciences LLC Irvine , CA 92614 |
Approval for the addition of an inspection for the 3.8 oz jar used to package the bioprosthetic heart valves. |
P880086/S108 12/7/05 180-Day |
Victory Pulse Generator Models: XL DR 5816, DR 5810 and SR 5610 |
St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for the Victory Pulse Generator models XL DR 5816, DR 5810 and SR 5610. |
P890003/S093 12/22/05 Real-Time |
Medtronic Pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P890014/S008 12/14/05 180-Day |
ETI-HA-IGMK PLUS Kit |
DiaSorin, Inc. Stillwater , MN 55082 |
Approval for change to the assay cutoff calculation that is designed to reduce the number of low level, non-clinically relevant positive results reported by the ETI-HA-IGMK PLUS Assay. |
P890019/S012 12/12/05 Special |
ETI-AB-HAVK PLUS |
DiaSorin S.p.A. Saluggia, Italy 13040 |
Approval for change in the manufacturing process for the Neutralizing Solution (HAV Reagent). |
P900061/S059 12/22/05 Real-Time |
Medtronic Pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P910016/S015 12/12/05 Special |
LCS® Uni Knee System |
DePuy Orthopaedics, Inc. Warsaw , IN 46581 |
Approval for changes in quality controls to the LCS Preservation Uni Mobile Bearing Inserts approved in P910016/S012. The changes include modifications to several Manufacturing Process Specifications (MPS) for Gamma Vacuum Foil (GVF) packaged products: 1) to add physical separation barriers to the sealing machine to prevent adjacent foil pouches from overlapping during the sealing operation, and 2) to require a second 100% inspection of the seal integrity of each package prior to shipment. |
P910023/S080 12/16/05 Real-Time |
St. Jude Medical ICD/CRT-D Implantable Devices |
St. Jude Medical CRMD Sunnyvale , CA 94086 |
Approval for the elimination of an extra layer of parylene coating that is applied over the high voltage capacitor prior to its installation into the device assembly during the ICD/CRT-D Manufacturing. |
P910071/S007 12/16/05 Real-Time |
ADATO® SIL-OL 5000 Silicone Oil with syringe (Catalog number: ES 5000 S) |
Bausch and Lomb, Inc. San Dimas , CA 91773 |
Approval for 1) change of the tip cap of the 10 mL HYPAC SCF syringe from containing dry natural rubber material to latex-free material and 2) revision of the labeling to remove the “dry natural rubber” statement. |
P910077/S054 12/2/05 Real-Time |
Renewal 3 RF ICDs |
Guidant Corporation St. Paul , MN 55112 |
Approval for the Model 6482 Communicator LATITUDE with Application v1.6 and System Application Software (SAS) with Application v1.1.1. |
P910077/S055 12/20/05 Real-Time |
Guidant ZOOM Programmer |
Guidant Corporation CRM St. Paul , MN 55112 |
Approval for the Heart failure PARTNER™ Model 2936 Maintenance Release Software (SW) version 1.5. |
P920015/S032 12/1/05 135-Day |
Medtronic Sprint Fidelis Leads Models 6930/6931, 6948/6949 |
Medtronic, Inc. St. Paul , MN 55126 |
Approval to change the aeration time following sterilization of the Sprint Fidelis Leads. |
P920047/S030 12/23/05 180-Day |
EPT 1000TC and EPT 1000XP Cardiac Ablation System |
Boston Scientific Corporation San Jose , CA 95134 |
Approval for a manufacturing site located at Plexus Electronic Assembly, Buffalo Grove , Illinois . |
P930014/S016 12/16/05 Real-Time |
Acrysof® Toric Single-Piece Natural Intraocular Lens (IOL) Models SN60T3, SN60T4 and SN60T5 |
Alcon Laboratories Fort Worth , TX 76134 |
Approval for IOL models SN60T3, SN60T4 and SN60T5. The device, as modified, will be marketed under the trade name Acrysof® Toric Single-Piece Natural IOL and is indicated for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved spectacle independence for distance vision. |
P930022/S002 12/22/05 Real-Time
|
Medtronic pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P940031/S045 12/21/05 135-Day |
Discovery and Meridian Family of Implantable Pacemakers |
Guidant Corporation Minneapolis , MN 55112 |
Approval for the addition of inspection tests, materials, alternate suppliers and manufacturing instructions. |
P950005/S018 12/16/05 180-Day |
Celsius™ RMT Diagnostic/Ablation Deflectable Tip Catheters, Model D-1249-02-S |
Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for adding remote magnetic navigation technology to the previously approved catheter. The device, as modified, will be marketed under the trade name Celsius RMT diagnostic/Ablation Deflectable Tip Catheters and is indicated for catheter-based atrial and ventricular electrophysiologic mapping and for use with the Stereotaxis Magnetic Navigation System (MNS) and compatible radiofrequency generators in adults and children four (4) years of age or older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias. |
P950037/S041 12/21/05 Real-Time |
CYLOS Family of Pulse Generators |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the CYLOS DR/DR-T and CYLOS VR Pulse Generators and the A-K00.6.U Programmer Software (for use with the EPR 1000 PLUS and TMS 1000 PLUS Programmers); the 504.U Programmer Software (for use with the ICS 3000 Programmer; and the home Monitoring Service Center II Version 1.8.0. |
P960009/S035 12/6/05 Special |
Medtronic Activa® Deep Brain Stimulation (DBS) System |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for recommending maximum displayed head SAR to be 0.1 W/kg with respect to the MRI (magnetic resonance imaging) instructions. |
P960028/S013 12/21/05 180-Day |
ARRAY® Multifocal Posterior Chamber Intraocular Lens Models SA40N, SA40N2, SA40e, AA40E, AA50 and NXG1 |
Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Approval for modification of the indication statement with standardized language for the models of the ARRAY® family of Multifocal Intraocular Lenses (Models SA40N, SA40N2, SA40e, AA40E, AA50 and NXG1). The devices, as modified, will be marketed under the trade name ARRAY® and are indicated for: the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed and who desire near, intermediate, and distance vision without reading add and increased spectacle, independence. |
P960040/S087 12/21/05 135-Day |
Vitality HE Family of Implantable Cardioverter Defibrillators |
Guidant Corporation Minneapolis , MN 55112 |
Approval for the addition of inspection tests, materials, alternate suppliers and manufacturing instructions. |
P960058/S043 12/23/05 180-Day |
HiResolution™ Bionic Ear System, HiRes 90K™ (with Helix Electrode) Coil-Case/Electrode Subassembly Final Molding Process |
Advanced Bionics Corporation Sylmar , CA 91342 |
Approval for process control improvements to the HiRes90K Coil-Case/Electrode subassembly final molding process. The proposed changes include an external thermocouple to provide closed-loop control of the mold temperature, thereby providing better control of the curing temperature of the silicone, and by configuring the mold tool with spring washer ( Belleville washers) to allow for smoother movement. The device, as modified, will be marketed under the trade name HiResolution™ Bionic Ear System and is indicated for individuals aged 12 months and older with severe-to-profound sensorineural hearing loss to restore a level of auditory sensation via electrical stimulation of the auditory nerve. |
D970003/S050 12/21/05 135-Day |
Discovery, Insignia, Intelis, Meridian , Nexus, Pulsar and Pulsar Max Family of Implantable Pacemakers |
Guidant Corporation Minneapolis , MN 55112 |
Approval for the addition of inspection tests, materials, alternate suppliers and manufacturing instructions. |
P970003/S062 12/28/05 Real-Time |
NeuroCybernetic Prosthesis (NCP) System |
Cyberonics, Inc. Houston , TX 77058 |
Approval for the Model 250 Programming Software – Version 7.2 for use with Model 100 Versions B and C, Model 101 Versions 1 and 2, and Models 102 and 102R pulse generators. |
P970004/S035 12/23/05 Real-Time |
Interstim® - Therapy for Urinary Control |
Medtronic CRM Minneapolis , MN 55432 |
Approval to include filtered feedthroughs in the right hand shield assembly. |
P970012/S019 12/22/05 Real-Time |
Medtronic Pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P980016/S063 12/22/05 Real-Time |
Medtronic Pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P980035/S051 12/22/05 Real-Time |
Medtronic Pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P980050/S019 12/22/05 Real-Time |
Medtronic Pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P990001/S022 12/22/05 Real-Time |
Medtronic Pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P000007/S010 12/6/05 Special |
Edwards Prima Plus Stentless Bioprosthesis, Model 2500P |
Edwards Lifesciences LLC Irvine , CA 92614 |
Approval for the addition of an inspection for the 3.8 oz jar used to package the bioprosthetic heart valves. |
P000029/S013 12/12/05 135-Day |
Deflux®
|
Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Approval for performing the protein testing in-house at the Q-Med Quality Control Laboratory and to change the test method so as to allow for the detection of lower amounts of protein. The device, as modified, will be marketed under the trade name Deflux® and is indicated for the treatment of vesicoureteral reflux in children. |
P010001/S002 12/12/05 135-Day |
Ceramic TRANSCEND Hip Articulation System |
CeramTec AG Bethesda , MD 20817 |
Approval for a change in the polishing and lapping manufacturing process and equipment. |
P010003/S007 12/8/05 180-Day |
BioGlue® Surgical Adhesive |
CryoLife, Inc. Kennesaw , GA 30144 |
Approval for a 10 mL syringe volume; a softer polymer in the piston of the syringe; an alternate supplier for the polyethylene for the cap plug of the entire delivery system product line; and addition of a 10 pack of pouched (4/pouch) standard syring tips. |
P010012/S077 12/21/05 135-Day |
Contact Renewal 3 Family of Cardiac Resynchronization Defibrillators |
Guidant Corporation Minneapolis , MN 55112 |
Approval for the addition of inspection tests, materials, alternate suppliers and manufacturing instructions. |
P010012/S084 12/20/05 Real-Time |
CONTAK Renewal Family of Cardiac Resynchronization Therapy Devices (CRT-D) |
Guidant Corporation CRM St. Paul , MN 55112 |
Approval for the Heart failure PARTNER™ Model 2936 Maintenance Release Software (SW) version 1.5. |
P010015/S018 12/22/05 Real-Time |
Medtronic Pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P010031/S032 12/22/05 Real-Time |
Medtronic Pacemaker and Implantable Defibrillator Models used with the Medtronic Model 2090 CareLink Programmer |
Medtronic CRM Minneapolis , MN 55432 |
Approval for software enhancements to the Model 9986 Desktop/Baseline Operating System Software (BOSS) versions 1.3.8 and 1.5 for the Medtronic Model 2090 CareLink Programmer. |
P010032/S018 12/21/05 Real-Time |
Genesis, Genesis RC and the Eon Neurostimulation Systems |
Advanced Neuromodulation Systems Plana , TX 75024 |
Approval for the 90 cm and 110 cm length versions of the ANS 3100 and 3200 series leads, which are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. |
P010041/S010 12/6/05 Special |
Carpentier-Edwards® Supraannular (S.A.V.) Bioprosthesis, Model 2650 |
Edwards Lifesciences LLC Irvine , CA 92614 |
Approval for the addition of an inspection for the 3.8 oz jar used to package the bioprosthetic heart valves. |
P020025/S014 12/23/05 180-Day |
EPT 1000TC and EPT 1000XP Cardiac Ablation System |
Boston Scientific Corporation San Jose , CA 95134 |
Approval for a manufacturing site located at Plexus Electronic Assembly, Buffalo Grove , Illinois . |
P020030/S002 12/29/05 135-Day |
Stelix II BRF 2XD |
ELA Medical Inc. Plymouth , MN 55441 |
Approval for additional incoming acceptance and final device testing. |
P030005/S021 12/21/05 135-Day |
Contact Renewal TR Family of Cardiac Resynchronization Pacemakers |
Guidant Corporation Minneapolis , MN 55112 |
Approval for the addition of inspection tests, materials, alternate suppliers and manufacturing instructions. |
P030005/S027 12/20/05 Real-Time |
CONTAK Renewal Family of Cardiac Resynchronization Therapy Pacemakers (CRT-P) |
Guidant Corporation CRM St. Paul , MN 55112 |
Approval for the Heart failure PARTNER™ Model 2936 Maintenance Release Software (SW) version 1.5. |
P030009/S003 12/22/05 Real-Time |
Medtronic Vascular Driver Rapid Exchange Coronary Stent System |
Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a series of manufacturing changes to the Medtronic Vascular Driver Rapid Exchange Coronary Stent System. |
P030017/S011 12/9/05 Real-Time |
PRECISION™ Spinal Cord Stimulation (SCS) System |
Advanced Bionics Sylmar , CA 91342 |
Approval for the Passing Elevator. |
P030031/S001 12/19/05 180-Day |
Biosense Webster NaviStar™/ Celsius™ ThermoCool® Diagnostic/Ablation Deflectable Tip Catheters |
Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval of the post-approval study for the device. |
P030054/S011 12/16/05 Real-Time |
St. Jude Medical ICD/CRT-D Implantable Devices |
St. Jude Medical CRMD Sunnyvale , CA 94086 |
Approval for the elimination of an extra layer of parylene coating that is applied over the high voltage capacitor prior to its installation into the device assembly during the ICD/CRT-D Manufacturing. |
P040003/S001 12/30/05 180-Day |
Exablate® 2000 MRI Guided Focused Ultrasound System |
InSightec, Inc. – North America Dallas , TX 75207 |
Approval for a manufacturing site located at InSightec Image Guided Treatment Ltd., Tirat Carmel , Israel . |
P040016/S004 12/16/05 180-Day |
Liberte™ Monorail® and Over-the-Wire Coronary Stent Systems |
Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for updated labeling that incorporates the results from the ELECT study. |
P040023/S002 12/12/05 Special |
Duraloc Option Ceramic-on-Ceramic Hip System |
DePuy Orthopedics, Inc. Warsaw , IN 46581 |
Approval for changes in quality controls to various components of this system. These changes include modification to several Manufacturing Process Specifications (MPS) for Gamma Vacuum Foil (GVF) packaged products: 1) to add physical separation barriers to the sealing machine to prevent adjacent foil pouches from overlapping during the sealing operation, and 2) to require a second 100% inspection of the seal integrity of each package prior to shipment. |
P040023/S003 12/22/05 Special |
Duraloc Option Ceramic-on-Ceramic Hip System |
DePuy Orthopedics, Inc. Warsaw , IN 46581 |
Approval for changes to the labeling that include: 1) the addition of an intraoperative precaution advising the surgeon of the necessity for correct positioning of the insert component prior to assembling it to the metal outer shell and examining the ceramic liner following final assembly, and 2) updating the Adverse Event table to reflect the higher rate of intraoperative chipping experienced in the first six months of U.S. distribution. |
P040027/S002 12/8/05 135-Day |
Gore VIATORR® TIPS Endoprosthesis |
W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 |
Approval to change certain manufacturing processes from a manual process to a semi-automated process. The device, as modified, will be marketed under the trade name Gore VIATORR TIPS Endoprosthesis and is indicated for use in de novo and revision treatment of portal hypertension and its complications such as variceal bleeding, gastropathy, ascites, and/or hepatic hydrothorax. |
P040034/S002 12/13/05 Real-Time |
DuraSeal™ Dural Sealant System |
Confluent Surgical, Inc. Waltham , MA 02451 |
Approval for changing the package configurations to include a 1 unit configuration, identified as “1-up”. |
P980018/S005 12/30/05 Special |
Hercep Test™ |
Dako Denmark A/S |
Approval for changes in quality control steps. |
P980018/S003 12/30/05 180-Day |
Hercep Test™ |
Dako Denmark A/S |
Approval for a manufacturing site located at Dako Denmark A/S, Glostrup, Denmark. |
P810006/S023 12/29/05 |
CollaStat® Absorbable Collagen Hemostatic Agents |
Integra Life Sciences, Corporation Plainsboro , NJ 08536 |
Manufacturing equipment change. |
P840062/S010 12/29/05 |
CollaCote Absorbable Collagen Wound Dressing |
Integra Life Sciences, Corporation Plainsboro , NJ 08536 |
Manufacturing equipment change. |
P840064/S030 12/21/05 |
DisCoVisc™ Ophthalmic Viscosurgical Device |
Alcon Research, Ltd. Fort Worth , TX 76134 |
Change in syringe vendor. |
P850010/S020 12/29/05 |
Helistat® Absorbable Collagen Hemostatic Agents |
Integra Life Sciences, Corporation Plainsboro , NJ 08536 |
Manufacturing equipment change. |
P900033/S013 12/29/05 |
INTEGRA® Dermal Regeneration Template |
Integra Life Sciences, Corporation Plainsboro , NJ 08536 |
Manufacturing equipment change. |
P910073/S059 12/8/05 |
RELIANCE Family of Leads |
Guidant Corporation St. Paul , MN 55112 |
Addition of a second supplier for the fluoro ring component used for identifying the position of the electrode during fluoroscopy. |
P910073/S060 12/15/05 |
ENDOTAK RELIANCE Family of Leads |
Guidant Corporation St. Paul , MN 55112 |
Retroactive changes made to the IS-1 (international standard lead connector), DF-1 (defibrillator connector) terminal crimp, and DF-1 distal fitting stake for ENDOTAK RELIANCE family of leads. |
P910073/S061 12/30/05 |
ENDOTAK RELIANCE G/SG Leads |
Guidant Corporation St. Paul , MN 55112 |
Change in manufacturing process that improves the distal coil bonding process by 1) changing the constitution of the bonding adhesive, 2) changing the tool used to apply the bonding adhesive, and 3) adding diagrams to the manufacturing instructions for the leads. |
|
12/19/05 |
Discovery / Meridian |
Guidant Corporation St. Paul , MN 55112 |
Addition of an Automated Inspection Vision System. |
P940040/S006 12/14/05 |
Roche AMPLICOR® Mycobacteriumtuberculosis Test |
Roche Molecular System, Inc. Pleasanton , CA 94566 |
Change to the purification process. |
P950034/S028 12/5/05 |
Seprafilm® Adhesion Barrier |
Genzyme Biosurgery Corporation Cambridge , MA 02142 |
Change in performance specifications to eliminate ethanol and isopropyl alcohol testing from Seprafilm Quality Control release criteria. |
P960006/S019 12/8/05 |
FLEXTEND Family of Leads |
Guidant Corporation St. Paul , MN55112 |
Addition of a second supplier for the fluoro ring component used for identifying the position of the electrode during fluoroscopy. |
P960040/S089 12/19/05 |
Prizm / Vitality |
Guidant Corporation St. Paul , MN 55112 |
Addition of an Automated Inspection Vision System. |
P960040/S090 12/15/05 |
VITALITY CRT-D |
Guidant Corporation St. Paul , MN 55112 |
Change the application of medical adhesive onto the device header from a manual to an automated process. |
P960058/S048 12/5/05 |
HiResolution Bionic Ear System |
Advanced Bionics Corporation Sylmar , CA 91343 |
Elimination of the Residual Gas Analysis (RGA-a destructive test) lot sampling for the HiRes90K implant. |
D970003/S053 12/19/05 |
Discovery / Pulsar Max/Insignia / Nexus / Intelis |
Guidant Corporation St. Paul , MN 55112 |
Addition of an Automated Inspection Vision System. |
D970003/S054 12/22/05 |
INSIGNIA / NEXUS Family of Implantable Pacemakers |
Guidant Corporation St. Paul , MN 55112 |
Change to implement the production of an additional subassembly on a previously qualified inner lead bonding machine. |
P000014/S013 12/8/05 |
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Change in the manufacturing equipment to pack coated wells. |
P000044/S010 12/8/05 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Change in the manufacturing equipment to pack coated wells. |
P010012/S080 12/19/05 |
Contak Renewal |
Guidant Corporation St. Paul , MN 55112 |
Addition of an Automated Inspection Vision System. |
P010021/S008 12/8/05 |
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Change in the manufacturing equipment to pack coated wells. |
P030005/S024 12/19/05 |
Contak Renewal TR |
Guidant Corporation St. Paul , MN 55112 |
Addition of an Automated Inspection Vision System. |
P030009/S004 12/22/05 |
DRIVER Coronary Stent System Family of Products |
Medtronic Vascular Santa Rosa, CA 95403 |
Change in an approved supplier’s processing steps to allow them to further process a subassembly in accordance with your own manufacturing operations and device specifications. |
P030024/S004 12/8/05 |
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Change in the manufacturing equipment to pack coated wells. |
P030026/S009 12/8/05 |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Change in the manufacturing equipment to pack coated wells. |
P040014/S002 12/8/05 |
IBI Therapy Ablation Catheters |
Irvine Biomedical, Inc. Irvine , CA 92614 |
Change to the tube fusing process and a change in the adhesive used in the weld joint process. |
P040016/S007 12/21/05 |
Liberte Coronary Stent System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Addition of another stainless steel tubing raw material supplier. |
P040042/S001 12/21/05 |
IBI Therapy™ Dual 8™ Ablation Catheters |
Irvine Biomedical, Inc. Irvine , CA 92614 |
Change in the tube fusing process and a change in the adhesive. |
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 62
Summary of PMA Originals Under Review
Total Under Review: 91
Total Active: 37
Total On Hold: 54
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 399
Total Active: 219
Total On Hold: 180
Number Greater Than 180 Days: 8
Summary of All PMA Submissions Received
Originals: 7
Supplements: 135
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 62
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 77.9
FDA Time: 60.7 Days MFR Time: 17.2 Days
Updated April 18, 2006
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
