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PMA Final Decisions Rendered for August 2003 |
 |
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| P020021 8/1/03 |
Wizard X-Cell™ Photodynamic Therapy Balloon with Fiber Optic Diffuser |
Axcan Scandipharm, Inc. Birmingham, AL 35242 |
Approval for the Wizard X-Cell™ Photodynamic Therapy Balloon with Fiber Optic Diffuser, which requested approval for use with the photosensitive drug PHOTOFRIN for the indication for use for ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy. |
|
8/25/03 |
EP Technologies EPT-1000 XP™ RF Ablation System |
Boston Scientific Corporation San Jose, CA 95134 |
Approval for the EP Technologies EPT-1000 XPä RF Ablation System. The Blazer II XP™ Cardiac Ablation Catheter is indicated for use with the EPT-1000 XP Cardiac Ablation Controller and Accessories for the treatment of sustained or recurrent type I atrial flutter in patients age 18 or older. The EPT-1000 XP™ Cardiac Ablation Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. |
|
8/13/03 |
INDEPEN-DENCE™ iBOT™ 3000 Mobility System |
Independence Technology, L.L.C. Warren, NJ 07059 |
Approval for the INDEPEN-DENCE™ iBOT™ 3000 Mobility System. The device is indicated for individuals who have mobility impairments and the use of at least one upper extremity. The device is intended to provide up to five operating functions. The purposes of these functions are 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 descent of stairs with or without assistance; and mobility and transportation of the unoccupied product. |
|
8/12/03 |
S.M.A.R.T.™ Nitinol Stent System and S.M.A.R.T.™ Control™ Nitinol Stent System |
Cordis Corporation Miami Lakes, FL 33014 |
Approval for the S.M.A.R.T.™ Nitinol Stent System and S.M.A.R.T.™ Control™ Nitinol Stent System. The devices are indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries up to 126 mm in length, with a reference vessel diameter of 4 to 9 mm, and angiographic evidence of a patient profunda or superficial femoral artery. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| N12159/S018 8/20/03 Real-Time |
SURGICELL/ SURGICELL NU-KNIT/SURGICELL Fibrillar Absorbable Hemostat |
Ethicon, Inc. Somerville, NJ 08876 |
Approval for labeling change to include four antibiotic resistant bacterial strains to the existing list of bacterial strains. |
| P790027/S069 8/13/03 Real-Time |
Polymethylmetha-crylate (PMMA) Intraocular Lenses (IOLs) |
Bausch & Lomb Surgical, Inc. San Dimas, CA 91773 |
Approval to modify the Directions for Use for all legally marketed IOLs under the referenced PMAs, to indicate the IOLs for use in adult patients. Previously, the IOLs were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary Implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods. |
| P810025/S022 8/19/03 135-Day |
Amvisc and Amvisc Plus |
Bausch & Lomb San Dimas, CA 91773 |
Approval for a change in the use of hyaluronic acid powder as an alternate raw material and for the use of an alternate endotoxin test. |
| P830045/S087 8/15/03 Real-Time |
ADx Pulse Generator family firmware SW9020091, Rev C and Model 3307 v4.4.2a software |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for modifications to the firmware of the ADx family of pulse generators and for programming software Model 3307 v4.4.2a to implement the modified firmware in implanted devices. |
| P840039/S051 8/13/03 Real-Time |
Polymethylmetha-crylate (PMMA) Intraocular Lenses (IOLs) |
Bausch & Lomb Surgical, Inc. San Dimas, CA 91773 |
Approval to modify the Directions for Use for all legally marketed IOLs under the referenced PMAs, to indicate the IOLs for use in adult patients. Previously, the IOLs were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary Implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods. |
| P850059/S024 8/13/03 Real-Time |
Polymethylmetha-crylate (PMMA) Intraocular Lenses (IOLs) |
Bausch & Lomb Surgical, Inc. San Dimas, CA 91773 |
Approval to modify the Directions for Use for all legally marketed IOLs under the referenced PMAs, to indicate the IOLs for use in adult patients. Previously, the IOLs were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary Implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods. |
| P860002/S018 8/13/03 Real-Time |
Polymethylmetha-crylate (PMMA) Intraocular Lenses (IOLs) |
Bausch & Lomb Surgical, Inc. San Dimas, CA 91773 |
Approval to modify the Directions for Use for all legally marketed IOLs under the referenced PMAs, to indicate the IOLs for use in adult patients. Previously, the IOLs were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary Implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods. |
| P870013/S016 8/13/03 Real-Time |
Polymethylmetha-crylate (PMMA) Intraocular Lenses (IOLs) |
Bausch & Lomb Surgical, Inc. San Dimas, CA 91773 |
Approval to modify the Directions for Use for all legally marketed IOLs under the referenced PMAs, to indicate the IOLs for use in adult patients. Previously, the IOLs were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary Implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods. |
| P870056/S015 8/22/03 180-Day |
Carpentier-Edwards® Bioprostheses, Models 2625 (aortic) & 6625 (mitral), and Carpentier-Edwards® Bioprosthetic Valved Conduit, Model 4300 |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for the replacement of the package temperature indicator to the TagAlert™ electronic temperature indicator (high and low). |
| P870073/S017 8/13/03 Real-Time |
Polymethylmetha-crylate (PMMA) Intraocular Lenses (IOLs) |
Bausch & Lomb Surgical, Inc. San Dimas, CA 91773 |
Approval to modify the Directions for Use for all legally marketed IOLs under the referenced PMAs, to indicate the IOLs for use in adult patients. Previously, the IOLs were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary Implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods. |
| P880081/S029 8/25/03 Special |
UV-Absorbing Silicone Posterior Chamber Intraocular Lens (IOLs) |
Advanced Medical Optics Santa Ana, CA 92799 |
Approval to modify the directions for use to include an additional precaution/warning statement regarding storage conditions: “Avoid exposure to volatile chemicals.” |
| P880086/S095 8/15/03 Real-Time |
ADx Pulse Generator family firmware SW9020091, Rev C and Model 3307 v4.4.2a software |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for modifications to the firmware of the ADx family of pulse generators and for programming software Model 3307 v4.4.2a to implement the modified firmware in implanted devices. |
| P880090/S018 8/13/03 Real-Time |
Polymethylmetha-crylate (PMMA) Intraocular Lenses (IOLs) |
Bausch & Lomb Surgical, Inc. San Dimas, CA 91773 |
Approval to modify the Directions for Use for all legally marketed IOLs under the referenced PMAs, to indicate the IOLs for use in adult patients. Previously, the IOLs were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary Implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods. |
| P890055/S016 8/12/03 Real-Time |
Model 3000 Series Implantable Infusion Pumps |
Codman and Schurtleff, Inc. Raynham, MA 02767 |
Approval for the following changes: 1) replace the currently approved catheter kit (AP-07002) with the IP-36633 and IP-3757 kits, 2) replace IP-36633 and IP-3757 connector with Codman 3000 (AP-07002) connector, and include an alternative connector material, 3) add additional components to the kit as a convenience to the physicians and 4) labeling change to the FlexTip Plus Intraspinal Catheter Kit Instructions for Use to reflect the correct catheter volume. |
| P900060/S025 8/1/03 Real-Time |
CarboMedics Carbo-Seal Valsalva™ Ascending Aortic Prosthesis (AAP) |
CarboMedics, Inc. Austin, TX 78752 |
Approval for an extension of shelf life from one to five years for the CarboMedicsCarbo-Seal Valsalva™ Ascending Aortic Prosthesis (AAP). |
| P910001/S024 8/8/03 180-Day |
Spectranectics Vitesse Cos RX Catheters, Vitesse E Catheters and Extreme OTW Catheters |
Spectranetics Corp. Colorado Springs, CO 80907 |
Approval for changes to Instructions for Use, including changes to the Contraindications section, for the Vitesse Cos RX, Vitesse E, and Extreme OTW Catheters. |
| P910023/S068 8/15/03 Real-Time |
ADx Pulse Generator family firmware SW9020091, Rev C and Model 3307 v4.4.2a software |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for modifications to the firmware of the ADx family of pulse generators and for programming software Model 3307 v4.4.2a to implement the modified firmware in implanted devices. |
| P910031/S021 8/1/03 180-Day |
JOMED JOCATH® Gladiator PTCA Catheter (OTW) |
JOMED, Inc. San Diego, CA 92128 |
Approval for the JOMED JOCATH® Gladiator PTCA Catheter (OTW). The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
| P910056/S008 8/13/03 Real-Time |
Silicone Intraocular Lenses |
Bausch & Lomb Surgical, Inc. San Dimas, CA 91773 |
Approval to modify the Directions for Use for all legally marketed IOLs under the referenced PMAs, to indicate the IOLs for use in adult patients. Previously, the IOLs were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary Implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods. |
| P910058/S012 8/13/03 Real-Time |
Silicone Intraocular Lenses |
Bausch & Lomb Surgical, Inc. San Dimas, CA 91773 |
Approval to modify the Directions for Use for all legally marketed IOLs under the referenced PMAs, to indicate the IOLs for use in adult patients. Previously, the IOLs were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary Implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods. |
| P910061/S009 8/13/03 Real-Time |
Silicone Intraocular Lenses |
Bausch & Lomb Surgical, Inc. San Dimas, CA 91773 |
Approval to modify the Directions for Use for all legally marketed IOLs under the referenced PMAs, to indicate the IOLs for use in adult patients. Previously, the IOLs were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary Implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods. |
| P910065/S004 8/12/03 180-Day |
ST AIA-PACK PA |
TOSOH Bioscience, Inc. South San Francisco, CA 94080 |
Approval for design changes to include reduction of the incubation time from 40 to 10 minutes, change in the conjugate diluent, decrease in ALP activity and change in packaging size from 200 tests to 100 tests per box. The device, as modified, will be marketed under the trade name ST AIA-PACK PA and is indicated for: ST AIA-PACK PA is designed for in vitro diagnostic use only for the quantitative measurement of Prostate Specific Antigen (PSA) in human serum on TOSOH AIA Nex•IA and TOSOH AIA-600 II analyzers. This device is indicated for the measurement of serum PSA in conjunction with Digital Rectal Examination (DRE) as an aid in the detection of prostate cancer (CaP) in men fifty years of age and older. Prostate biopsy is required for the diagnosis of cancer. The device is further indicated for the serial measurement of PSA in human serum to be used as an aid in the management of patients with prostatic cancer. |
| P910066/S017 8/1/03 180-Day |
OL 1000, OL 1000 SC, and SpinaLogic Bone Growth Stimulators |
OrthoLogic Corp. Tempe, AZ 85281 |
Approval for various labeling, software and hardware changes. |
| P920023/S016 Special |
UroLume® Endoprosthesis |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for additional detailed instructions for prosthesis removal after urothelial coverage. |
| P930014/S011 8/29/03 Real-Time |
Acrysof® Single-Piece Posterior Changer Intraocular Lens (IOL) with the Acrysert™ Delivery System (Model SA60AS) |
Alcon Laboratories, Fort Worth, TX 76134 |
Approval for the Acrysof® Single-Piece Posterior Changer Intraocular Lens (IOL) with the Acrysert™ Delivery System (Model SA60AS), and for a shelf life extension protocol. |
| P930039/S016 8/25/03 Real-Time |
Model 5076 CapSure Fix Novus Electrode |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for Titanium Nitride coating of the electrode helix tip. |
| P940010/S010 8/1/03 Panel |
OPTIGUIDE™ Fiber Optic Diffuser (DCYL Cylindrical Diffuser Series) |
Diomed, Inc. Cambridge, UK CB5 9TE |
Approval for use with the photosensitive drug PHOTOFRIN for the additional indication for use for the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy. |
| P950037/S030 8/4/03 180-Day |
Philos DR ACC Pacing System and Programmer Software version B-KAC.V.U/1 |
BIOTRONIK, Inc. Lake Oswego, OR 97053 |
Approval for a modified Philos DR Pacing System. The device, as modified, will be marketed under the trade name Philos DR ACC Pacing System and Programmer Software version B-KAC.V.U/1 and is indicated for use in patients with standard bradycardia pacing indications. Rate-adaptive pacing with the Philos DR ACC pulse generator is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual chamber or atrial pacing modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing. |
| P960028/S009 8/29/03 180-Day |
Array® 2 Model SA44 Multifocal Intraocular Lens (IOL) |
Advanced Medical Optics Santa Ana, CA 92799 |
Approval for extending the power range of the Array® 2 Model SA44 Multifocal IOL up to 35 diopters. |
| P960028/S010 8/25/03 Special |
Array® Multifocal UV-Absorbing Silicone Posterior Chamber IOLs |
Advanced Medical Optics Santa Ana, CA 92799 |
Approval to modify the directions for use to include an additional precaution/warning statement regarding storage conditions: “Avoid exposure to volatile chemicals.” |
| D970003/S022 8/5/03 Real-Time |
INSIGNIA I Entra and INSIGNIA I Plus Implantable Pacemaker System |
Guidant Corporation St. Paul, MN 55112 |
Approval for firmware and software modifications, including a software patch to correct observations reported on the atrial tachycardia response (ATR) feature and other enhancements to the Autolifestyle feature. |
| P970003/S047 8/14/03 Real-Time |
NeuroCybernetic Prothesis (NCP) System |
Cyberonics, Inc. Houston, TX 77058 |
Approval for the NeuroCybernetic Prothesis (NCP) System Model 102R Generator, human factors improvements to the Model 102 Generator and labeling changes to the Model 302 lead which are indicated for use as an adjunctive therapy in reducing the frequency of seizures that are refractory to antiepileptic medications. |
| P980003/S008 8/7/03 180-Day |
Chilli® Cooled Ablation System |
EP Technologies, Inc. San Jose, CA 95134 |
Approval for a change in the post-approval study protocol to allow for the maximum limit of 40 patients or 20 percent of the total study enrollment at any one site. |
| P980035/S019 8/7/03 180-Day |
Kappa 900/800 Pacemaker Series and Model 9988 Software Series 1.1 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for expanded programmable upper tracking rate options and post mode switch overdrive pacing. |
| P980053/S006 8/26/03 180-Day |
Durasphere® EXP |
Carbon Medical Technologies, Inc. St. Paul, MN 55110 |
Approval for a modified bead specification (90-212 µm) for the pyrolytic carbon coated zirconium oxide and graphite beads. The device, as modified, will be marketed under the trade name Durasphere® EXP and is indicated for use in the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). |
| P990014/S003 8/13/03 Real-Time |
Hydroview IOLs |
Bausch & Lomb Surgical, Inc. San Dimas, CA 91773 |
Approval to modify the Directions for Use for all legally marketed IOLs under the referenced PMAs, to indicate the IOLs for use in adult patients. Previously, the IOLs were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary Implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods. |
| P990017/S038 8/8/03 180-Day |
ANCURE® System |
Guidant Corporation Menlo Park, CA 94025 |
Approval for the format to be used for the clinical update that will be provided to physicians users at least annually. The information contained in this update will be provided to the FDA via the PMA annual Report. |
| P990021/S001 8/1/03 Panel |
Diomed 630 PDT Laser, Model T2USA |
Diomed, Inc. Cambridge, UK CB5 9TE |
Approval for use with the photosensitive drug PHOTOFRIN for the additional indication for use for the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy. |
| P990026/S019 8/28/03 180-Day |
GlucoWatch G2 Biographer |
Cygnus, Inc. Redwood City, CA 94063 |
Approval of a post-approval study protocol for the device. |
| P990038/S005 8/20/03 Special |
DiaSorin ETI-MAK-2 PLUS Assay |
DiaSorin, Inc. Saluggia, Italy |
Approval for a revision in the assay package insert that incorporates a change in the interpretation algorithm for repeat testing results that make it the same as the interpretation for initial testing. “The user should apply the same interpretation of results (i.e. reactive samples should have an absorbance value greater than 90% of the cutoff) when initial testing for some samples and repeat testing for other samples are performed on the same plate.” |
| P990046/S007 8/1/03 Real-Time |
ATS Open Pivot® Bileaflet Heart Valve, APEX Aortic Models 503DA16, 503DA18, 503DA20, 503DA22, 503DA24, 503DA26, and 503DA28, and APEX Mitral Models 503DM24, 503DM26, and 503DM28 |
ATS Medical Minneapolis, MN 55447 |
Approval for a cuff design change. The device, as modified, will be marketed under the trade name ATS Open Pivot® Bileaflet Heart Valve, APEX Aortic Models 503DA16, 503DA18, 503DA20, 503DA22, 503DA24, 503DA26, and 503DA28, and APEX Mitral Models 503DM24, 503DM26, and 503DM28 and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. |
| P000015/S005 8/22/03 Real-Time |
Nucleus 24 Auditory Brainstem Implant – Addition of PET Mesh Disk |
Cochlear Americas Englewood, CO 80112 |
Approval for the addition of a Polyterephthalate (PET) Mesh Disk. The device, as modified, will be marketed under the trade name Nucleus 24 Auditory Brainstem Implant with PET Mesh Disk and is intended to restore useful hearing in individuals with Neurofibromatosis Type 2 (NF2) who are 12 years of age or older, via electrical stimulation of the cochlear nucleus. |
| P000025/S009 8/27/03 180-Day |
MED-EL COMBI 40+ Cochlear Implant System |
MED-EL Corporation Durham, NC 27713 |
Approval for the COMBI 40+ System Medium Active Electrode Array (C40+M) to be part of the C40+ Cochlear Implant System (Implant C40+ with standard C40+, split C40+ GB, and compressed C40+ S electrode Arrays). |
| P000032/S003 8/8/03 180-Day |
Her Option™ Cryoablation Therapy System |
American Medical Systems, Gynecology, Inc. San Diego, Ca 92121 |
Approval for early termination of the Clinical Technique Standardization post-approval study. |
| P000041/S002 8/8/03 180-Day |
RapidScreen® RS-2000D |
Deus Technologies, Rockville, MD 20850 |
Approval for a second device name of “RapidScreen Digital” (abbreviated “RS-Digital”). |
| P000057/S002 8/11/03 Real-Time |
Ascension MCP |
Ascension Orthopedics, Inc. Austin, TX 78754 |
Approval to extend the shelf life expiration date from 2 years to 4 years. |
| P010032/S008 8/22/03 Real-Time |
Genesis Neurostimulation (IPG) System |
Advanced Neuromodulation Systems, Inc. Plano, TX 75024 |
Approval for the use of the Model A127 Lead Extension (Models 2341, 2342, 2343 and 2346) 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. |
| P010033/S004 8/7/03 Real-Time |
QuantiFERON-TB |
Cellestis, Inc. Valencia, CA 91355 |
Approval for the use of the QuantiFERON-TB Analysis Software Program for use with the QuantiFERON-TB Test. The device accessory will be marketed under the trade name QuantiFERON-TB Analysis Software Program and is indicated as a stand alone program for Analysis of raw EIA data and calculation of QuantiFERON-TB assay results. |
| P010034/S003 8/11/03 180-Day |
Second Look® Digital CAD System for Mammography |
CADx Systems, Inc. Beavercreek, OH 45431 |
Approval for the Second Look® Digital CAD System for GEMS Senographie 2000D Full Field Digital Mammography. The changes include software upgrade to accommodate digital image processing and an addition of rack mountable hardware. The device, as modified, will be marketed under the trade name Second Look® Digital CAD System for Mammography and is indicated for identification and marking regions of interest on screening and diagnostic mammograms from General Electric Medical Systems Senographie 2000D Full Field Digital mammography system to bring them to the attention of the radiologist after the initial reading has been completed. |
| P010049/S008 8/13/03 Real-Time |
QuickSeal™ Control Arterial Closure System |
Sub-Q, Inc. San Clemente, CA 92673 |
Approval to modify the device to reduce the number of preparation steps, simplify the method of staging the hemostatic sponge into delivery cannula and provide an easier interface for flushing the Depth Marker. |
| P020037/S001 8/28/03 180-Day |
FX MiniRAIL™ RX PTCA Catheter |
Guidant Corporation Temecula, CA 92591 |
Approval for a manufacturing site located at Guidant Corporation Vascular Intervention Group, Temecula, California. |
| P020052/S001 8/22/03 Real-Time |
Cardioversion Switchbox II System |
St. Jude Medical, Daig Division, Inc. Minnetonka, MN 55345 |
Approval for the Cardioversion Switchbox II System. The device is indicated as follows: The Cardioversion Switchbox II System connects a St. Jude Medical Cardioversion (CV) Catheter and extension cable to a compatible cardioverter/ defibrillator and EP Recording System. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| P990020/S014 8/8/03 |
AneuRx™ Stent Graft with Xpedient Delivery System |
Medtronic Endovascular Innovations Santa Rosa, CA 95403 |
Change in the manufacturing process of the AneuRx™ Stent Graft with Xpedient Delivery System which involves a change in the method of the joining process for both the 16 Fr and 12 FR delivery systems. |
| P990020/S016 8/29/03 |
AneuRx™ Stent Graft with Xpedient Delivery System |
Medtronic Endovascular Innovations Santa Rosa, CA 95403 |
Elimination of the destructive functional testing of sterile finished devices. |
| P990026/S020 8/20/03 |
GlucoWatch® Automatic Glucose Biographer |
Cygnus, Inc. Redwood City, CA 94063 |
Change to the manufacturing process of the GlucoWatch Biographer AutoSensor to add a secondary visual inspection of the AutoSensors rejected by the automated, camera-based inspection to increase product yield and reduce production costs. |
| P990075/S012 8/15/03 |
Mentor Spectrum™ Saline-Filled Mammary Prostheses |
Mentor Corporation Santa Barbara, CA 93111 |
Change in the supplier for the silicone elastomer fill tube. |
| P990075/S013 8/14/03 |
Mentor Spectrum™ Saline-Filled Mammary Prostheses |
Mentor Corporation Santa Barbara, CA 93111 |
Change in the Quality control test specification to replace the tensile strength specification with a break force specification for the silicone elastomer fill tube component of the Mentor Spectrum™ Saline-Filled Mammary Prostheses. |
| P000039/S006 8/21/03 |
AMPLATZER® Septal Occluder and PFO Occluder AMPLATZER® 45º Delivery and exchange Systems |
AGA Medical Corporation Golden Valley, MN 55427 |
Alternate supplier for the delivery sheath, dilator, and loading device components of the AMPLATZER® Septal Occluder and AMPLATZER® 45 º delivery and Exchange Systems and some minor manufacturing changes to allow for color coding of components. |
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 52
Summary of PMA Originals Under Review
Total Under Review: 77
Total Active: 35
Total On Hold: 42
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 240
Total Active: 129
Total On Hold: 111
Number Greater Than 180 Days: 6
Summary of All PMA Submissions Received
Originals: 5
Supplements: 59
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 52
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 103.7
FDA Time: 80.6 Days
MFR Time: 23.1 Days
Updated 9/25/2003
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