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PMA Final Decisions Rendered for March 2005 |
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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.
3/7/05 |
ADVIA Centaur® HAV Total Assay, ADVIA Centaur® HAV Total Quality Control Materials |
Bayer Healthcare, LLC Tarrytown , NY 10591 |
Approval for the ADVIA Centaur® HAV Total Assay and Quality Control Materials. HAV Total Assay Indication for Use: The ADVIA Centaur HAV Total Assay is an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to hepatitis A virus (anti-HAV ) in human serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur System. This anti-HAV assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination. HAV Total Quality Control Materials Indication for Use: For monitoring the performance of the HAV Total Assay on ADVIA Centaur® Systems. The performance of the HAV Total Quality Control Material has not been established with any other anti-HAV Total Assay. |
3/21/05 |
AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber Intraocular Lenses, Models MA60D3 and SA60D3 |
Alcon Research Ltd. Fort Worth , TX 76134 |
Approval for the AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber Intraocular Lenses (IOLs), Models MA60D3 and SA60D3. This device is indicated for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. |
3/25/05 |
Restylane™ Injectable Gel |
Medicis Aesthetics Holdings, Inc. Scottsdale , AZ 85258 |
Approval for the Restylane™ Injectable Gel. The device is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. |
3/23/05 |
GORE TAG Thoracic Endoprosthesis |
W.L. Gore and Associates Flagstaff , AZ 86001 |
Approval for the TAG Thoracic Endoprosthesis and delivery catheter. The device is intended for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy including: 1) Adequate iliac/femoral access. 2) Aortic inner diameter in the range of 23-37 mm. 3) ≥2 cm non-aneurysmal aorta proximal and distal to the aneurysm. |
PMA Supplemental Approvals
P790017/S082 3/4/05 Real-Time |
NC Stormer MX 2 and OTW Balloon Dilatation Catheters |
Medtronic Vascular, Inc. Santa Rosea , CA 95403 |
Approval for addition of the NC Stormer MX 2 catheter with two additional lengths (as a modified version of the approved NC Stormer MX catheter) and the addition of two additional lengths for the NC Stormer OTW catheter. |
P810032/S051 3/4/05 135-Day |
PMMA VS-100 MP PC IOL |
Alcon Research LTD. Fort Worth , TX 76134 |
Approval for the use of an additional supplier of polymethylmethacrylate (PMMA) for the PMMA IOLs. |
P840060/S029 3/4/05 135-Day |
PMMA Single-Piece IOL |
Alcon Research LTD. Fort Worth , TX 76134 |
Approval for the use of an additional supplier of polymethylmethacrylate (PMMA) for the PMMA IOLs. |
P840064/S026 3/23/05 180-Day |
DisCoVisc™ Ophthalmic Viscosurgical Device |
Alcon Research Ltd. Fort Worth , TX 76134 |
Approval for the DisCoVisc™ Ophthalmic Viscosurgical Device. |
P860004/S064 3/24/05 Real-Time |
SynchroMed Infusion System |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for modifications to the labeling of the SynchroMed EL pumps to increase the shelf life of the 10mL pumps to 24 months and the 18mL pumps to 48 months. |
P860004/S067 3/2/05 Special |
SynchroMed Programmable Infusion Pumps |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for changes to the warning statements of the Technical Manuals for both the SynchroMed EL and SynchroMed II Programmable Infusion Pumps. |
P860004/S068 3/10/05 Special |
Medtronic Model 8516 Percutaneous Intraspinal Catheter Kit |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for a technical manual addendum to be added to the packaged catheter kit to strengthen the instructions for the proper use of the connector. |
P870072/S033 3/22/05 180-Day |
Thoratec® Ventricular Assist Device (VAD System |
Thoratec Corporation Pleasanton , CA 94588 |
Approval for a contract sterilization site located at Tri-State Hospital Supply Corporation, Yuma , Arizona and for a change in the cytotoxicity testing process. |
P880086/S102 3/8/05 Real-Time |
Model 3307 v.4.8.3 and Model 3307 v.4.8.4 Programmer Software |
St. Jude Medical, Inc. Sunnyvale , CA 94086 |
Approval for Model 3307 v.4.8.3 and Model 3307 v.4.8.4 Programmer Software. |
P880087/S011 3/4/05 135-Day |
PMMA Single-Piece Anterior Chamber IOL |
Alcon Research LTD. Fort Worth , TX 76134 |
Approval for the use of an additional supplier of polymethylmethacrylate (PMMA) for the PMMA IOLs. |
P890003/S081 3/31/05 Real-Time |
Medtronic Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices. The CareLink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection. |
P890057/S018 3/10/05 Real-Time |
Model 3100B High-Frequency Oscillatory Ventilatory (HFOV) |
Bird Products Corporation Palm Springs , CA 92262 |
Approval for modifications to the heat and filter on the exhaled gas limb of the existing patient circuit. |
P900023/S042 3/23/05 Real-Time |
ABIOMED® AB5000™ Circulatory Support System |
ABIOMED, Inc. Danvers , MA 01923 |
Approval for a change to only the AB5000 Circulatory Support System that will allow the user an alternate means of reducing blood flow during weaning by adjusting the level of vacuum applied to the AB5000 Blood Pump. |
P900023/S043 3/11/05 Real-Time |
ABIOMED® BVS5000 Bi-Ventricular Support System and AB5000™ Circulatory Support System |
ABIOMED, Inc. Danvers , MA 01923 |
Approval for the addition of four new inflow cannulae (32/42 Fr Apical Cannula with Side Holes and 32/42 Fr Apical Cannula without Side Holes) for use with the BVS5000 Bi-Ventricular Support System and the AB5000™ Circulatory Support System. |
P910023/S076 3/1/05 Real-Time |
Epic™ and Epic™+ DR/VR ICD Systems with N2 Capacitor |
St. Jude Medical Sylmar , CA 91342 |
Approval for the Epic™ and Epic™+ DR/VR ICD Systems with N2 Capacitor. |
P910077/S048 3/2/05 Real-Time |
Heart Failure PARTNER Model 2936 with software version 1.1 |
Guidant Corporation St. Paul , MN 55112 |
Approval for the Heart Failure PARTNER Model 2936 with software version 1.1 which is indicated for interrogating and downloading diagnostic information obtained by Guidant’s pacemaker and defibrillator Cardiac Resynchronization Therapy (CRT-P and CRT-D) devices. |
P920014/S025 3/22/05 180-Day |
HeartMate LVAS System |
Thoratec Corporation Pleasanton , CA 94588 |
Approval for a contract sterilization site located at Tri-State Hospital Supply Corporation, Yuma , Arizona and for a change in the cytotoxicity testing process. |
3/17/05 Panel-Track |
STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) |
VISX, Inc. Santa Clara , CA 95051 |
Approval for the VISX STAR S4 IR Excimer Laser System with VSS and WaveScan WaveFront System. The device uses a 6.0 mm optical zone, a 9.0 mm treatment zone, and is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): 1) for the reduction or elimination of naturally occurring mixed astigmatism when the magnitude of cylinder (from 1.0 to 5.0 D) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs; 2) in patients 21 years of ago or older; and 3) in patients 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 pre-operative examination. |
P950015/S010 3/21/05 180-Day |
The Heart Laser CO2 TMR System |
PLC Medical Systems, Inc. Franklin , MA 02038 |
Approval for modifications to the electronic pre-ignition system used by the laser medical device. |
P950020/S011 3/8/05 180-Day |
Cutting Balloon Monorail (MR) |
Boston Scientific San Diego , CA 92123 |
Approval for an alternate in-house sterilization site located in Quincy , Massachusetts . |
P950020/S012 3/16/05 180-Day |
Ultra2 Cutting Balloon Monorail (MR) |
Boston Scientific San Diego , CA 92123 |
Approval for manufacturing sites located at Interventional Technologies Europe, Ltd., Donegal , Ireland and EBIS Iotron, Ltd., Oxon , Great Britain . |
P950039/S014 3/18/05 180-Day |
ThinPrep 2000 System |
Cytyc Corporation Marlborough , MA 01752 |
Approval for a manufacturing site located at Cytyc Corporation, Marlborough , Massachusetts . |
P960028/S011 2/23/05 180-Day |
Soft Acrylic Multifocal Array® 2 (Models AA40e and AA50) and ReZoom™ (Model NXG1) Intraocular Lenses |
Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Approval for Soft Acrylic Multifocal Array® 2 (Models AA40e and AA50) and ReZoom™ (Model NXG1) Intraocular Lenses. |
P960040/S051 3/1/05 Real-Time |
Vitality™ HE Model T182 Implantable Cardioverter Defibrillator (ICD) System and the Consult Programmer Software Application Model 2896 Version 1.0 |
Guidant Corporation St. Paul , MN 55112 |
Approval for the Vitality HE Model T182 Implantable Cardioverter Defibrillator (ICD) System and the Consult Programmer Software Application Model 2896 Version 1.0. The device is indicated for use as follows: Guidant ICDs are intended to provide ventricular antitachycardia pacing and ventricular arrhythmias. |
P960052S010 3/21/05 Real-Time |
High Viscosity DERMABOND® Topical Skin Adhesive |
Closure Medical Corporation Raleigh , NC 27616 |
Approval for the addition of ProPen and ProPen XL applicators. The device, as modified, will be marketed under the trade names High Viscosity DERMABOND ProPen Topical Adhesive and High Viscosity DERMABOND ProPen XL Topical Skin Adhesive products and are indicated for topical application to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. High Viscosity DERMABOND ProPen and ProPen XL may be used in conjunction with, but not in place of subcuticular sutures. DERMABOND Adhesive may be used in conjunction with, but not in place of deep dermal stitches. |
P960058/S040 3/7/05 180-Day |
HiResolution™ Bionic Ear System |
Advanced Bionics Corporation Sylmar , CA 91342 |
Approval for upgrades to the Auria PowerPak™ for the HiRes™ Auria Processor (Behind-the-Ear). |
P970051/S028 3/1/05 180-Day |
Nucleus 24 Cochlear Implant System |
Cochlear Americas Englewood , CO 80112 |
Approval for a new receiver/stimulator component (CI24RE), a new speech processor (SP12), the PIF4 Programming Interface, the CS14 Programming Software, and upgraded Neural Response Telemetry Software (EPS5). |
P980006/S006 3/17/05 Real-Time |
Bausch & Lomb® PureVision™ Toric (balafilcon A) Visibility Tinted Contact Lens |
Bausch & Lomb Rochester , NY 14609 |
Approval for the toric design with an extended wear indication for up to 30 days continuous wear between removals. The device, as modified, will be marketed under the trade name Bausch & Lomb Pure Vision Toric (balafilcon A) Visibility Tinted Contact Lens and is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters that does not interfere with visual acuity. The lens maybe prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00 to -9.00D when prescribed for up to 30 days of extended wear and from +20.00D to -20.00D for daily wear or extended wear up to 7 days. |
P980016/S047 3/31/05 |
Medtronic Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices. The CareLink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection. |
P990001/S017 3/16/05 Real-Time |
Vitatron C60 DR (Model C60A3) and Vitatron C20 SR (Model C20A3) Implantable Pulse Generators and their associated software (VSF11/VSF12 version 1.0); and the T-series application software (VSF07/VSF08 version 1.2); and CD-ROM (VSE03/VSE04 version 2.3) |
Vitatron Minneapolis , MN 55432 |
Approval for the Vitatron C60 DR (Model C60A3) and Vitatron C20 SR (Model C20A3) Implantable Pulse Generators and their associated software (VSF11/VSF12 version 1.0); and the T-series application software (VSF07/VSF08 version 1.2); and CD-ROM (VSE03/VSE04 version 2.3). |
P990009/S013 3/10/05 180-Day |
FloSeal® Hemostatic Matrix |
Baxter Healthcare Corporation Westlake Village , CA 91362 |
Approval for an alternate kit configuration that contains a human thrombin component. The device, as modified, will be marketed under the trade name FloSeal® Hemostatic Matrix and is indicated for use in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. |
P990009/S016 3/31/05 Real-Time |
FloSeal® Matrix Hemostatic Agent and FloSeal® Endoscopic Applicator |
Baxter Healthcare Corporation Westlake Village , CA 91362 |
Approval for a modification to the Endoscopic Applicator and a modification of the “Indication for Use” for the Endoscopic Applicator. The device, as modified, will be marketed under the trade name FloSeal® Endoscopic Applicator and is indicated for use in delivering FloSeal® Matrix Hemostatic Sealant to bleeding surgical sites through a 5 mm or larger trocar. |
P990071/S006 3/21/05 Special |
Stockert 70 Radiofrequency Ablation Generator |
Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for labeling changes that strengthen the instructions for use. |
P000054/S006 3/11/05 Real-Time |
InFUSE™ Bone Graft |
Medtronic Sofamor Danek Memphis , TN 38132 |
Approval for use of new shipping container. The new container is lighter than the current container and uses polystyrene insulation instead of polyurethane. |
P000058/S017 3/11/05 Real-Time |
InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device |
Medtronic Sofamor Danek Memphis , TN 38132 |
Approval for use of new shipping container. The new container is lighter than the current container and uses polystyrene insulation instead of polyurethane. |
P010013/S011 3/7/05 180-Day |
NovaSure® Impedance Controlled Endometrial Ablation System |
Cytyc Surgical Products Palo Alto , CA 94303 |
Approval for revised Instructions for Use, including results from the three-year follow up, improved consistency, and a revision to the Contraindications regarding long-term medical therapy. |
P010013/S012 3/24/05 180-Day |
NovaSure® Global Impendence Controlled Endometrial Ablation System |
Cytyc Surgical Products Palo Alto , CA 94303 |
Approval for a manufacturing site located at Cytyc Surgical Products, Heredia , Costa Rica . |
P010017/S005 3/7/05 180-Day |
SensoScan Full Field Digital Mammography System |
Fischer Imaging Corporation Denver , CO 80241 |
Approval for addition of automatic exposure system, and related changes in Operator’s Manual and QC test and QC Manual under MQSA. |
P010031/S019 3/31/05 Real-Time |
Medtronic Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices. The CareLink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection. |
P010032/S014 3/4/05 Real-Time |
Genesis Neurostimulation System |
Advanced Neuromodulation Systems, Inc. Plano , TX 75024 |
Approval for the Eon Neurostimulation System, Model 3716, which is 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. |
P010038/S009 3/7/05 180-Day |
Second Look® Digital Computer-aided Detection System |
iCAD, Inc. Beavercreek , OH 45431 |
Approval for private label distribution (Hologic, Inc. to distribute Second Look®). The device, as modified, will be marketed under the trade name SecurLook™ and is indicated for: The SecurLook™ computer-aided detection system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas of the original mammogram that may warrant a second review. |
P020009/S017 3/9/05 Real-Time |
Express/Express 2 ™ Coronary Stent System (Monorail, MR and Over-the-Wire, OTW) |
Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for modifications to labeling contained in the Warnings/ Precautions sections of the Directions for Use (DFU) and Patient Guides based upon updated safety information related to Magnetic Resonance Imaging (MRI) performed at 3 Tesla. |
P020022/S002 3/25/05 Real-Time |
Bayer VERSANT HCV RNA 3.0 Assay (bDNA) |
Bayer HealthCare LLC Berkeley , CA 94702 |
Approval for addition of laboratory information system interface (Version 1.0) to the Bayer System 340 bDNA Analyzer DMS. |
P020023/S011 3/11/05 Special |
Restylane |
Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Approval for changes in product labeling. |
P020033/S002 3/15/05 180-Day |
INDEPEN-DENCE™ iBOT™ 4000 Mobility System |
Independence Technology, L.L.C. Warren , NJ 07059 |
Approval for generational changes to the approved device. The device, as modified, will be marketed under the trade name INDEPEN-DENCE™ iBOT™ 4000 Mobility System. The device is indicated for individuals who have mobility impairments and the use of at least on upper extremity. The device is intended to provide mobility on smooth surfaces and inclines at home, at work ,and in other environments; movement across obstacles, uneven terrain, curbs, grass, gravel and other soft surfaces; mobility in a seated position at an elevated height; ascent and decent of stairs with or without assistance; and mobility and transportation. |
P020045/S007 3/29/05 Real-Time |
7F Freezor Cardiac CryoAblation Catheter & CCT.2 Cryoconsole System |
CryoCath Technologies, Inc. Quebec , Canada H9H 5H3 |
Approval for a modification from temperature to flow control in cryoablation mode of the 7F Freezor Cardiac CryoAblation Catheter & CCT.2 Cryoconsole. |
P030005/S005 3/8/05 180-Day |
Guidant CONTAK RENEWAL TR Models H125 and H120 |
Guidant Corporation St. Paul , MN 55112 |
Approval for modified device labeling to describe the COMPANION clinical study. |
P030006/S003 3/24/05 180-Day |
Celsion Prolieve™ Thermodilatation System |
Celsion Corporation Columbia , MD 21046 |
Approval of a modified post-approval study for the device. |
P030025/S005 3/31/05 180-Day |
TAXUS Express2 Coronary Stent System |
Boston Scientific Corporation |
Approval to use Steris Isomedix (formerly Cosmed of Rhode Island) as an alternate sterilization site for devices manufactured at Galway, Ireland. |
P030006/S004 3/11/05 Real-Time |
Prolieve™ Thermodilatation System |
Celsion® Corporation Columbia , MD 21046 |
Approval for a new ink to be used to mark the catheter component of the device using the same pad printing process for applying these markings. |
P030025/S010 3/9/05 Real-Time |
TAXUS Express 2 ™ Paclitaxel-Eluting Coronary Stent System (Monorail, MR and Over-the-Wire, OTW) |
Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for modifications to labeling contained in the Warnings/ Precautions sections of the Directions for Use (DFU) and Patient Guides based upon updated safety information related to Magnetic Resonance Imaging (MRI) performed at 3 Tesla. |
P030054/S005 3/8/05 Real-Time |
Model 3307 v.4.8.3 and Model 3307 v.4.8.4 Programmer Software |
St. Jude Medical, Inc. Sunnyvale , CA 94086 |
Approval for Model 3307 v.4.8.3 and Model 3307 v.4.8.4 Programmer Software. |
P030054/S006 3/30/05 Real-Time |
Epic, Epic+, and Epic HE ICD Systems |
St. Jude Medical, Inc. Sunnyvale , CA 94086 |
Approval for a new capacitor used in the Epic, Epic+, and Epic HE ICD Systems. |
30-Day Notices (135 Day Supplement was not required)
P810031/S026 3/4/05 |
Healon® Sodium Hyaluaronate Viscoelastic Products |
Advanced Medical Optics Santa Ana , CA 92705 |
Change in vendor of a raw material for Healon® products. |
P870025/S007 3/24/05 |
Corometrics Model 146 Fetal Acoustic Stimulator |
GE Medical Systems Information Technologies Tampa , FL 33614 |
Change in manufacturer for the plastic housing. |
P910073/S050 3/24/05 |
ENDOTAK® Family (includes ENDOTAK®, ENDOTAK ENDURANCE, ENDOTAK RELIANCE®) |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedure for inspections of leads with drug subassemblies. |
P950001/S014 3/24/05 |
SELUTE Family (includes SELUTE, SELUTE PICOTIP) |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedure for inspections of leads with drug subassemblies. |
P960004/S028 3/24/05 |
FINELINE® Family (includes FINELINE®, FINELINE® II) |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedure for inspections of leads with drug subassemblies. |
P960006/S014 3/24/05 |
SWEET TIP Rx Family (includes SWEET TIP Rx, SWEET PICOTIP Rx, FLEXTEND® Family) |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedure for inspections of leads with drug subassemblies. |
P970051/S030 3/30/05 |
Nucleus 24 Implant System |
Cochlear Americas Englewood , CO 80112 |
Change of supplier for three silicone products (Silicone HCRP 50, Silicone LSR 30, and RTV Silicone Adhesive) and change the catalyst in two additional silicone products (MED4515 & MED4516). |
P980003/S014 3/1/05 |
Chilli II Cooled Ablation Catheter, Models M00490310, M0049031K2 and M0049031N4 |
Boston Scientific Corporation San Jose , CA 95134 |
Changes to the solder and adhesive application processes. |
P000014/S011 3/29/05 |
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators |
Ortho-Clinical Diagnostics Rochester , NY 14626 |
Change to the test and release limit that is applied to the dose-response curve shape parameters. |
P000015/S006 3/30/05 |
Nucleus 24 Auditory Brainstem Implant System |
Cochlear Americas Englewood , CO 80112 |
Change of supplier for three silicone products (Silicone HCRP 50, Silicone LSR 30, and RTV Silicone Adhesive) and change the catalyst in two additional silicone products (MED4515 & MED4516). |
P000032/S006 3/21/05 |
HerOption™ Cryoablation Therapy System |
American Medical Systems Minnetonka , MN 55343 |
Addition of a new type of filter to the cryostat, a change to enhance the corrosion resistance of the cryostat tubing and a change in the cryostat cleaning method. |
P010012/S043 3/24/05 |
EASYTRAK® Family (includes EASYTRAK®, EASYTRAK® 2, EASYTRAK® 3) |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedure for inspections of leads with drug subassemblies. |
P010018/S007 3/22/05 |
Viewpoint™ Conductive Keratoplasty System |
Refractec®, Inc. Irvine , CA 92618 |
Alternate manufacturing method for the Trocar and Stop subassembly of the disposable Keratoplast tip. |
P020008/S001 3/4/05 |
Karl Storz Autofluorescence System |
Karl Storz Endoscopy-America, Inc. Culver City , CA 90230 |
Change in the OEM sensor for the Karl Storz Autofluorescence System. |
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 53
Summary of PMA Originals Under Review
Total Under Review: 88
Total Active: 45
Total On Hold: 43
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 256
Total Active: 125
Total On Hold: 131
Number Greater Than 180 Days: 7
Summary of All PMA Submissions Received
Originals: 10
Supplements: 66
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 53
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 118.5
FDA Time: 89 Days MFR Time: 29.5 Days
Updated April 19, 2005
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