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PMA Final Decisions Rendered for April 1999 |
PMA ORIGINAL APPROVALS | |||
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME |
COMPANY NAME, CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
4/27/99 |
PRO-Trac II Tacrolimus ELISA Kit |
DiaSorin, Inc. Columbia, MD 21046 |
Approval for PRO-Trac II Tacrolimus ELISA Kit. This device indicated for the quantitative determination of tacrolimus (Prograf® FK506) and some metabolites in EDTA or heparinized human whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy. |
4/16/99 |
TransScan T-Scan 2000 |
TransScan Medical, Inc. Ramsey, NJ 07446 |
Approval for the TransScan T-Scan 2000. The device is intended for use as an adjunct to mammography in patients who have equivocal mammographic finding within ACR BI-RADS categories 3 or 4. In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy. This device provides the radiologist with additional information to guide a biopsy recommendation. |
4/9/99 |
KeraVision Intacs |
KeraVision, Inc. Fremont, CA 94538-7353 |
This device is indicated for the reduction or elimination of mild myopia (-1.00 to –3.00 diopters spherical equivalent at the spectacle plane) in patients: who are 21 yrs of age or older; with documented stability of refraction as demonstrated by a change of less than or equal to 0.50D for at least 12 months prior to the preoperative examination; and where the astigmatic components are +1.00D or less. |
4/28/99 |
Home Access® Hepatitis C Checksm and Hepatitis C Checksm Express |
Home Access Health Corporation Hoffman Estates, IL 60195-5200 |
Approval for the Home Access® Hepatitis C Checksm and Hepatitis C Checksm Express. This device is indicated for home use for collection of a dried blood spot specimen by finger-stick, and is indicated for anonymous testing for antibody to hepatitis C virus (HCV) in adults, eighteen years or older, who may have been exposed to HCV through transfusion or organ transplant before 1992, who may have injected non-prescription drugs, or who were exposed to infected needles or had sexual contacts with HCV infected individuals. |
PMA SUPPLEMENTAL APPROVALS | |||
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME |
COMPANY NAME, CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
N18286/S011 4/26/99 |
GELFOAM® Sterile Powder |
Pharmacia & Upjohn Company Kalamazoo, MI 49001-0199 |
Approval for changing the name of the product form Gelfoam Sterile Powder to Gelfoam Absorbable Gelatin Powder. |
P810002/S048 4/16/99 |
St. Jude Medical® Mechanical Heart Valve/SJM® Master Series Mechanical Heart Valve, Mitral Sizes 35mm and 37mm/SJM® Master Series Mechanical Heart Valve with Silzone Coating, Mitral Sizes 35mm and 37mm |
St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for the addition of 35mm and 37mm mitral valve sizes to the SJM® Master Series Mechanical Heart Valve product line (SJM Master Series with Polyester Cuff, model number MJ-501, and SJM® Master Series with Silzone coating, Polyester Cuff, model number MS-601). |
P810046/S194 4/14/99 |
ACS RX Solaris Coronary Dilatation Catheter |
Guidant Corporation Santa Clara, CA 95052 |
Approval for additional balloon sizes and an additional indication for use for the ACS RX Solaris Coronary Dilatation Catheter. The device as indicated for: a)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction. c) Balloon dilatation of the ACS MULTI-LINK DUET stent after implantation. |
P830045/S064* 4/21/99 |
Model 3510 Programmer with Model 3303 version 1.02 Software |
St. Jude Medical Sylmar, CA 91342 |
Approval for the Model 3510 Programmer with Model 3303 version 1.02 Software. The device, as modified, will be marketed under the trade name the Model 3510 Programmer with Model 3303 version 1.02 Software and is indicated for the programming and interrogation of implanted St. Jude Pacemakers. |
P850035/S024 4/7/99 |
SpF-2T, SpF-4T and SpF-XL IIb Implantable Spinal Fusion Stimulator |
Electro Biology, Inc. Parsippany, NJ 07054-1079 |
Approval for labeling changes stating the device was MR Safe. |
P850064/S015 4/5/99 |
Life Pulse High Frequency Ventilator |
Bunnell, Inc. Salt Lake City, UT 84115 |
Approval for extending the duration of use for the breathing circuit. |
P850079/S030 4/15/99 |
Frequency 55, CooperFlex, Envoy, Onevue, Sterling 55 and Clear Comfort (methafilcon A) Spherical and Frequency (methafilcon A) Toric Contact Lenses for Extended Wear (Clear and Handling Tint with In-Monomer Tinting Process, Cast-molded) |
COOPERVISION, Inc. Scottsville, NY 14546 |
Approval for an alternate tinting process, In-Monomer-Tinting Process. |
P860019/S150 4/8/99 |
SCIMED® NC MAXXUM Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
Scimed Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for the SCIMED NC MAXXUM PTCA Catheter (20mm balloon length with balloon diameters of 2.0mm, 2.5-4.0mm in 1/4mm increments and 4.5mm, - 5.0mm in 1/2mm increments; and 9mm and 15mm lengths with balloon diameters of 2.5-4.0mm in 1/4mm increments and 4.5mm – 5.0mm) in 1/2mm increments. The NC MAXXUM PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or byapss graft stenosis for the purpose of improving myocardial perfusion. The NC MAXUUM PTCA Catheter (balloon models 2.5-4.0mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents. |
P860019/S154* 4/5/99 |
ADANTE Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
Scimed Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for the ADANTE Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (20 mm length with balloon diameters of 1.5 mm, and 2.0 - 4.0 mm in 1/4 mm increments, and 30 and 40 mm lengths with balloon diameters of 2.0 – 4.0 mm in 1/4 mm increments). The ADANTE PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocaridal perfusion. The ADANTE PTCA Catheter (balloon models 2.5 - 4.0 mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents. |
P860019/S155* 4/9/99 |
SCIMED® Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
Scimed Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for minor labeling revisions to the Instructions for Use manual for the Scimed® PTCA Catheters. |
P870018/S023 4/30/99 |
Lithostar Multiline Lithotripter |
Siemens Medical, Systems, Inc. Iselin, NJ 08830 |
Approval for a manufacturing site located at Siemens AG, Roentgenstrasse 19- 21, Kemnath, Germany. Final assembly and system testing of the Lithostar Multiline will be performed at this facility. |
P880065/S004 4/12/99 |
Aortic Valvuloplasty Catheter |
SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for a manufacturing site located at SCIMED Life Systems, Inc., Two SCIMED Place, Maple Grove, MN 55311. |
P880086/S060* 4/21/99 |
Model 3510 Programmer with Model 3303 version 1.02 Software |
St. Jude Medical Sylmar, CA 91342 |
Approval for the Model 3510 Programmer with Model 3303 version 1.02 Software. The device, as modified, will be marketed under the trade name the Model 3510 Programmer with Model 3303 version 1.02 Software and is indicated for the programming and interrogation of implanted St. Jude Pacemakers. |
P900043/S013 4/15/99 |
PALMAZ-SCHATZ MiniCrown Balloon-Expandable Stent with Dynasty Over the Wire Delivery System |
Cordis Corporation Warren, NJ 07059 |
Approval for the PALMAZ-SCHATZ MiniCrown Balloon Expandable Stent with Dynasty Over the Wire Delivery System (11mm and 15mm stent lengths with 2.25, 2.50, 2.75, 3.00, and 3.25mm balloon diameters). The device is indicated for improving coronary luminal diameter in the following: Treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions (£ 25mm) with a reference vessel diameters in the range of 2.25 to 3.25mm. Long term outcome (beyond 1 month) for this permanent implant is unknown at present. |
P900052/S007 4/21/99 |
PORT-A-CATH® Epidural Implantable Access System |
SIMS Medical Systems St. Paul, MN 55112 |
Approval for a change in the postapproval protocol to allow the use of the Low Profile system which was approved on 10/28/98. |
P900061/S037 4/15/99 |
Medtronic® Model 7227 Cx GEM Implantable Cardioverter Defibrillator |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval to implement a new test Method and specification for screening the Medtronic® Model 7227 Cx GEM Implantable Defibrillators for premature battery depletion. |
P910023/S041* 4/19/99 |
Cadence® Tiered Therapy Defibrillator System |
St. Jude Medical, Inc. Sunnyvale, CA 94086-6527 |
Approval for an extension of the shelf life from 9 months to 18 months for the Contour® MD Model V-175 and the Contour® II Model V-185 Implantable Cardioverter Defibrillators. |
P910023/S042* 4/19/99 |
Cadence® Tiered Therapy Defibrillator System |
St. Jude Medical, Inc. Sunnyvale, CA 94086-6527 |
Approval for a labeling change to reflect compatibility of the Contour II/MD, Angstrom II/MD, and Profile II/MD implantable defibrillators with cellular phones. |
P910066/S013* 4/20/99 |
OrthoLogic 1000 Bone Growth Stimulator |
OrthoLogic Corporation Tempe, AZ 85281 |
Approval for updating the Patient Registry Data Sheet. |
P920023/S008 4/13/99 |
UroLume® Endoprosthesis |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for a windowless version of the UroLume® Endoprosthesis delivery tool. |
P920047/S010 4/14/99 |
EPT-1000 Cardiac Ablation System |
Boston Scientific/ EP Technologies San Jose, CA 95134 |
Approval for an alternate contract sterilizer and a change of biological indicator. |
P930038/S018 4/27/99 |
Angio-Seal Hemostatic Puncture Closure Device |
Kendall Company Bothell, WA 98021 |
Approval for a modification to the collagen sponge shape. |
P940016/S001 4/26/99 |
Heparin-Induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) System |
B.Braun Medical, Inc. Bethlehem, PA 18018 |
Approval for a change in the potting resin material (i.e., from polypropylene Valtech (Montell) HH-44 to polypropylene Pro-Fax PH920S) used to seal the end caps of the H.E.L.P. System Precipitate Filter. |
P950005/S004* 4/5/99 |
Celsius Diagnostic/Ablation Deflectable Braided Tip Catheter (5mm Tip Electrode) |
Cordis Webster, Inc. Diamond Bar, CA 91765 |
Approval for the 7 Fr and 8 Fr catheters incorporating a 5mm tip electrode. The device, as modified, will be marketed under the trade name Celsius Diagnostic/Ablation Deflectable Braided Tip Catheter (5mm Tip Electrode) and is indicated for interruption of accessory AV conduction pathways assocated with tachycardia, the treatment of AV nodal reentrant tachycardia (AVNRT), and creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia. In addition to these indications, the 7 Fr catheter is also indicated for persistent junctional reciprocating tachycardia, Mahaim fibers, and pediatric patients (age 4 years or older). |
P950015/S002 4/27/99 |
The Heart Laser CO2 TMR System |
PLC Medical Systems, Inc. Franklin, MA 02038 |
Approval for changes to the labeling. |
P960006/S001 4/9/99 |
SWEET PICOTIP Rx Models 4050, 4051, 4052, 4053, 4054, and 4055 Steroid Eluting, Positive-Fixation, Porous Tip Pacing Leads |
Guidant Corporation St. Paul, MN 55112-5798 |
Approval for several new lead models: the SWEET PICOTIP Rx Models 4050, 4051, 4052, 4053, 4054, and 4055 Steroid Eluting, Positive-Fixation, Porous Tip Pacing Leads. These devices are indicated for chronic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator. |
P960013/S005 4/9/99 |
Locator Steerable Stylet Model 4036 |
St. Jude Medical Sylmar, CA 91342 |
Approval for changes to the User's Manual and package label for the Locator Steerable Stylet Model 4036. |
P960020/S001 4/1/99 |
Reliance® Urinary Control Insert and Sizing Device |
UroMed Corporation Norwood, MA 02062 |
Approval for suspension of postapproval study because company is discontinuing manufacture and distribution of device. |
P960043/S011 4/9/99 |
Techstar® XL 6 French and Prostar® XL 8 and 10 French Percutaneous Vascular Surgical (PVS) Systems |
Perclose, Inc. Menlo Park, CA 94025 |
Approval for a modification to the suture lumen. |
P960057/S006 4/21/99 |
ADCON®-L Adhesion Control in a Barrier Gel |
Gliatech, Inc. Cleveland, OH 44122 |
Approval for extending the expiration dating for ADCON-L Adhesion Control in a Barrier Gel syringe configurations from 6 months to 12 months. The device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis. |
4/15/99 |
Medtronic® Interstim® System for Urinary Control |
Medtronic, Inc. Minneapolis, MN 55440-9087 |
Approval for the Medtronic® Interstim® System for Urinary Control. This device is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency/frequency in patients who have failed or could not tolerate more conservative treatments. |
P970017/S001 4/29/99 |
Hologic Sahara Clinical Bone Sonometer |
Hologic, Inc. Bedford, MA 01730 |
Approval for a change in the manufacturing site to 35 Crosby Dr., Bedford, MA 01730. |
P970035/S006 4/27/99 |
Micro Stent® II and GFX Over-the-Wire Coronary Stent Systems |
Arterial Vascular Engineering, Inc. Santa Rosa, CA 95403 |
Approval for the 5-year post-approval study protocol for the Micro Stent® II and GFX Over-the-Wire Coronary Stent Systems. |
P970035/S008 4/8/99 |
Medtronic AVE GFX® 2 Over-The-Wire Coronary Stent System |
Arterial Vascular Engineering, Inc. Santa Rosa, CA 95403 |
Approval for the Medtronic AVE GFX® 2 Over-The-Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length £ 30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 mm to 4.0 mm. Long term outcome (beyond six months) for this permanent implant is unknown at present. |
P970040/S001* 4/23/99 |
Achilles Express |
Lunar Corporation Madison, WI 53713 |
Approval for a design change that was primarily to replace the open water bath with water enclosed in silicone membranes. The device, as modified, will be marketed under the trade name Achilles Express and is indicated for: The Achilles Express ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by x-ray absorptiometry at the spine or hip. |
P970061/S002 4/21/99 |
SCIMED® RADIUS Coronary Stent with Delivery System |
Scimed Life Systems, Inc. Maple Grove, MN 55311-1566 |
Proposal for 5 year post-approval study protocol. |
P980016/S005 4/15/99 |
Medtronic® Model 7273 GEM II Dual Chamber Implantable Cardioverter Defibrillator |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for screening the Medtronic® Model 7271 GEM II Dual Chamber Implantable Cardioverter Defibrillators for premature battery depletion. |
P980023/S001 4/19/99 |
Phylax Implantable Cardioverter Defibrillator (ICD) System |
Biotronik, Inc. Lake Oswego, OR 97035-5369 |
Approval for modifications to the programmer software used with Biotronik's MycroPhylax and Phylax XM ICD's. |
P980035/S001* 4/1/99 |
Medtronic.Vision Software Models 9953/9953A – Series 1.3 |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for the Medtronic.Vision Software Models 9953 and 9953A (Series 1.3) for use with the Medtronic Model 9790 programmers to program the Medtronic Kappa 700 series pacemakers. The device, as modified, will be marketed under the trade name Medtronic.Vision Software Models 9953/9953A and is indicated for use with the Medtronic Kappa 700 series pacemakers to allow electrophysiology stimulation (EPS) functions. |
*Evaluated as a "Real-Time Review" PMA Supplement.
APPLICATION NUMBER & LTR DATE |
|
COMPANY NAME |
|
P860057/S010** 4/13/99 |
Carpentier-Edwards® PERIMOUNT® Pericardial Valve, Models 2700 and 2800 |
Baxter Healthcare Corporation Santa Ana, CA 92711-1150 |
The 30-day notice requested the following manufacturing changes: 1) Modify the environmental classification for the area in which wireforming operations are performed. 2) Add a validated cleaning process for the wireform in a class 10,000 environment prior to stent assembly. |
P870056/S011** 4/13/99 |
Carpentier-Edwards® Bioprosthesis, Model 2625 and 6625 |
Baxter Healthcare Corporation Santa Ana, CA 92711-1150 |
The 30-day notice requested the following manufacturing changes: 1) Modify the environmental classification for the area in which wireforming operations are performed. 2) Add a validated cleaning process for the wireform in a class 10,000 environment prior to stent assembly. |
P870077/S009** 4/13/99 |
Carpentier-Edwards® Duraflex Bioprosthesis, Models 6625LP and 6625LP-ESR |
Baxter Healthcare Corporation Santa Ana, CA 92711-1150 |
The 30-day notice requested the following manufacturing changes: 1) Modify the environmental classification for the area in which wireforming operations are performed. 2) Add a validated cleaning process for the wireform in a class 10,000 environment prior to stent assembly. |
P950032/S009** 4/19/99 |
Apligraf |
Organogenesis, Inc. Canton, MA 02021 |
The 30-day Notice requested a manufacturing process change for Apligraf . The requested change will place into the manufacturing process 3 additional production-scale incubators manufactured by Lunaire Corporation (model #CI0641W-6SPL). |
P970003/S019** 4/5/99 |
NeuroCybernetic Prosthesis System |
Cyberonics Webster, TX 77598 |
The 30-Day Notice requested relocation of the Seam Welding Equipment from the Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility. |
P970003/S020** 4/5/99 |
NeuroCybernetic Prosthesis System |
Cyberonics Webster, TX 77598 |
The 30-Day Notice requested relocation of the Feed Through Welding Equipment from the Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility. |
P970003/S021** 4/5/99 |
NeuroCybernetic Prosthesis System |
Cyberonics Webster, TX 77598 |
The 30-Day Notice requested relocation of the Laser Marking Equipment from the Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility. |
P970020/S012** 4/22/99 |
ACS Multi-Link RX Duet CSS and ACS Multi-Link OTW Duet CSS |
Guidant Corporation Vascular Intervention Group Temecula, CA 92591-4628 |
The 30-Day Notice requested that "end-product" pyrogen testing be performed on non-sterile samples prior to E-beam sterilization, in addition to the current method of testing sterile samples. |
P970034S003** 4/16/99 |
UV-PMMA Posterior Chamber Intraocular Lenses |
Ophthalmic Innovations International, Inc. Claremont, CA 91711 |
The 30-day Notice requested introduction of a manufacturing process change to use an alternate sterilization chamber (chamber #1) at Griffith MicroScience, the same sterilization contractor approved in the original PMA. Griffith is upgrading the chamber that was previously used. The proposed cycle is nearly identical to the currently-approved cycle for chamber #8, both chambers will use the computer-controlled process; the primary differences are that the chamber is smaller and an additional air wash with vacuum hold have beed added after the gas-dwell phase. |
**A 135 Day Supplement Was Not Required
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 39
Summary of PMA Originals Under Review
Total Under Review: 73
Total Active: 30
Total On Hold: 43
Number Greater Than 180 Days: 0
Summary of PMA Supplements Under Review
Total Under Review: 205
Total Active: 141
Total On Hold: 64
Number Greater Than 180 Days: 6
Summary of All PMA Submissions Received
Originals: 1
Supplements: 44
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 39
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 99.6
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