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PMA Final Decisions Rendered for August 1997

 related information

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 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
P940015

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.
P950035

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.
P970007

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.
P970008

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.
P910007/S004

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.

Updated April 7, 1998

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