Medical Devices
August 1997 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for August 1997. 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.
PMA Original Approvals
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
|
8/8/97 |
Synvisc® Hylan G-F 20 |
Biomatrix, Inc. Ridgefield, NJ 07657 |
This device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. |
|
8/15/97 |
Freehand System® |
NeuroControl Corporation Cleveland, OH 44106-4720 |
The system includes: implantable receiver-stimulator Model 202-1, implantable epimysial electrode set Model 203-1, surgical electrode positioning kit Model 207-1, patient external system Model 204-1, programming system Model 209-1. The system is an upper extremity neuroprosthesis and is intended to improve a patient's ability to grasp, hold, and release objects. The system is indicated for use in patients who: are tetraplegic due to C5 or C6 spinal cord injury (ASIA Classification); have adequate functional range of motion of the upper extremity; have intact lower motor neuron innervation of the forearm and hand musculature; and are skeletally mature. |
|
8/26/97 |
Imx® Tacrolimus II Assay |
Abbott Laboratories Abbott Park, IL 60064-3537 |
Approval for the Imx® Tacrolimus II Assay. This device is indicated for use as an in-vitro reagent system for the quantitative determination of tacrolimus and some metabolites in human whole blood as an aid in the management of liver allograft patients receiving tacrolimus therapy. |
|
8/22/97 |
T3® Targeted Transurethral Thermoablation System: Model 4000 |
Urologix, Inc. Minneapolis, MN 55447 |
This device is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH) and is indicated for mean with prostatic lengths of 30 to 50 millimeters. |
PMA Supplemental Approvals
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
|
N17004/S009 8/8/97 |
Surgical Simplex P Radiopaque Bone Cement |
Howmedica, Inc. Rutherford, NJ 07070-2584 |
Approval for alternative supplier of methyl methacrylate monomer. |
|
P790017/S063 8/26/97 |
USCI® ProCross Rely® SP Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel® Coating |
USCI Division, C.R. Bard, Inc. Billerica, MA 01821 |
Approval for the addition of ten models to the currently marketed line of USCI® ProCross Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel® Coating. The device, as modified, will be marketed under the trade name USCI® ProCross SP Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel® Coating and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
|
P810046/S180 8/12/97 |
ACS RX COMET Coronary Dilatation Catheter |
Guidant Corporation Santa Clara, CA 95052-8167 |
Approval for modification to the Instructions for Use. |
|
P820018/S071 8/7/97 |
Reflex Models 8218, 8220E, 8232, 8224 and 8223E Implantable Pulse Generators |
Pacesetter, Inc. Sylmar, CA 91392-9221 |
Approval for extension of shelf life from 12 months to 18 months. |
|
P840068/S033 8/8/97 |
Delta Pacemaker System, VENTAK PRx AICD System, VIGOR DR/SR Pacemaker System, and VENTAK AV AICD System |
Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798 |
Approval for software modifications to the Model 2090 Multiple Application Utility (MAU). |
|
P860019/S120 8/1/97 |
SCIMED® NC REBEL Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for the NC REBEL PTCA Catheter. |
|
P860019/S125 8/12/97 |
SCIMED® Quantum Ranger Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for additional balloon sizes (2.75 mm, 3.25 mm, and 3.75 mm) for the SCIMED® 15 mm and 20 mm Quantum Ranger PTCA Catheter. |
|
P860019/S126 8/12/97 |
SCIMED® Quantum Ranger Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for additional balloon sizes (22 mm, 30 mm, lengths with balloon sizes of 2.5 mm up to 4.0 mm in ¼ sizes) for the SCIMED® Quantum Ranger PTCA Catheter. |
|
P860064/S008 8/8/97 |
DuPen® Long-Term Epidural Catheter |
Bard Access Systems, Inc. Salt Lake City Utah, UT 84116 |
Approval for a change in the sterilant from 12% Freon/88% ethylene oxide to 100% ethylene oxide and to change the sterilization facility form Davol, Inc., a C.R. Bard facility in Cranston, R.I., to a contract sterilizer, Sorex Medical, Inc., in Salt Lake City, UT. |
|
P870024/S041 8/25/97 |
FluoroPerm (paflufocan A, B, C, and D) Rigid Gas Permeable Contact Lenses (Clear and Tinted) for Extended Wear |
Paragon Vision Sciences Mesa, AZ 85204 |
Approval for Viscon Contact Lens Manufacturing Ltd., 10214-112 Street, Edmonton, Alberta, Canada T5K1M4, as an alternate manufacturing and distribution site for the device. |
|
P870036/S043 8/12/97 |
The Medtronic® Millenia 15 Coronary Balloon Dilatation Catheter |
Medtronic Interventional Vascular, Inc. San Diego, CA 92121-2256 |
Approval for: a) the addition of 15 mm lengths to the Millenia Coronary Balloon Dilatation Catheter Line; b) a change in the method used to test for burst strength of the balloons; and c) the addition of the FOLIO Balloon Shaping Tool as an accessory. The device, as modified, will be marketed under the trade name Medtronic® Millenia 15 Coronary Balloon Dilatation Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
|
P880003/S067 8/8/97 |
Cordis Titan Mega PTCA Dilatation Catheters |
Cordis Corporation Miami Lakes, FL 33102-5700 |
Approval for the Cordis Titan Mega and Titan Mega XL family of PTCA Dilatation Catheters. |
|
P880098/S010 8/25/97 |
Menicon SF-P (melafocon A) Rigid Gas Permeable Contact Lens for Extended Wear |
Menicon, USA, Inc. Clovis, CA 93612-5613 |
Approval for an alternate packaging process where Barnes Hind® Comfort Care® GP Wetting and Soaking Solution is added to the lens shipping case. Lenses will be shipped wet with a storage period of up to 30 days from the date of hydration. |
|
P890064/S005 8/15/97 |
Human Papillomavirus DNA Typing Kit (Hybrid Capture® System HPV DNA Assay) |
Digene Diagnostics, Inc. Silver Spring, MD 20904 |
Approval for use of a cervical broom specimen collected and transported in the Cytyc Corporation PreservCyt® Solution for testing in the Digene Corporation Hybrid Capture System HPV DNA Assay. |
|
P900033/S002 8/7/97 |
INTEGRA Artificial Skin |
Integra LifeSciences, Corp. Plainsboro, NJ 08536 |
Approval for a 24 month expiration date for INTEGRA Artificial Skin. |
|
P900070/S014 8/27/97 |
Tempo DR Model 2102 and Tempo D Model 2902 Pulse Generators |
Pacesetter, Inc. Sylmar, CA 91392-9221 |
Approval for the Tempo DR Model 2102, Tempo D Model 2902, Tempo VR Model 1102, and Tempo V Model 1902 Pulse Generators. |
|
P900070/S016 8/7/97 |
Meta DDDR Model 1256 Implantable Pulse Generator |
Pacesetter, Inc. Sylmar, CA 91392-9221 |
Approval for extension of shelf life from 12 months to 18 months. |
|
P900070/S017 8/27/97 |
Tempo VR Model 1102 and Tempo V Model 1902 Pulse Generators |
Pacesetter, Inc. Sylmar, CA 91392-9221 |
Approval for the Tempo DR Model 2102, Tempo D Model 2902, Tempo VR Model 1102, and Tempo V Model 1902 Pulse Generators. |
|
8/7/97 |
Abbott Imx® and AxSYM® PSA assays |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the addition of a new intended use and is indicated for the quantitative measurement of Prostate Specific Antigen (PSA) in: 1) Human serum as an adjunctive test used as an aid in the management of prostate cancer patients; 2) Human serum as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men aged 50 years or older. Prostatic biopsy is required for diagnosis of cancer. |
|
P910023/S029 8/12/97 |
Contour Implantable Cardioverter Defibrillator System |
Ventritex, Inc. Sunnyvale, CA 94086-6527 |
Approval of additional headers (Models V-145 and V-145B) for the Contour Implantable Cardioverter Defibrillator System. |
|
P910077/S021 8/8/97 |
Delta Pacemaker System, VENTAK PRx AICD System, VIGOR DR/SR Pacemaker System, and VENTAK AV AICD System |
Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798 |
Approval for software modifications to the Model 2090 Multiple Application Utility (MAU). |
|
P940008/S006 8/13/97 |
Res-Q II ACD |
Sulzer Intermedics, Inc. Angleton, TX 77515-2523 |
Approval for a Dear Doctor Letter. |
|
P940031/S010 8/8/97 |
Delta Pacemaker System, VENTAK PRx AICD System, VIGOR DR/SR Pacemaker System, and VENTAK AV AICD System |
Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798 |
Approval for software modifications to the Model 2090 Multiple Application Utility (MAU). |
|
P950040/S003 8/15/97 |
Dr. Brown's Home Drug Testing System |
Personal Health and Hygiene, Inc. Baltimore, MD 21201 |
Approval for labeling in final printed form and for a change in the group providing phone services related to the device from Joseph J. Sheerin to National Medical Review Officers, Inc. |
|
P960004/S001 8/29/97 |
ThinLine EZ Model 438-10 Endocardial Pacing Lead |
Sulzer Intermedics Angleton, TX 77515 |
Approval for the ThinLine EZ Model 438-10 Endocardial Pacing Lead. This device is indicated for chronic pacing and sensing of the atrium or ventricle when used with a compatible pulse generator. |
|
P960040/S001 8/8/97 |
Delta Pacemaker System, VENTAK PRx AICD System, VIGOR DR/SR Pacemaker System, and VENTAK AV AICD System |
Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798 |
Approval for software modifications to the Model 2090 Multiple Application Utility (MAU). |
|
P9700003/S001 8/21/97 |
NeuroCybernetic Prosthesis (NCP) System |
Cyberonics, Inc. Webster, TX 77598-4135 |
Approval for a manufacturing site located at Texcel, Inc., E. Longmeadow, MA 01028. |
|
P970008/S001 8/28/97 |
Urologix Targis System |
Urologix, Inc. Minneapolis, MN 55447 |
Approval for a change in trade name. The device will now be marketed under the trade name Urologix Targis System and is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH) in men with prostatic lengths of 30 to 50 millimeters. |