MEDTRONIC PACING LEADS

FDA premarket approval P890003/S068 · decided 2002-03-01

Approval details

PMA number

P890003

Supplement

S068

Supplement type

Normal 180 Day Track

Trade name

MEDTRONIC PACING LEADS

Generic name

implantable pacemaker Pulse-generator

Applicant

Medtronic, Inc.

Date received

2001-10-15

Decision date

2002-03-01

Days to decision

137 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR MEDTRONIC MODEL 72 DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH M DR) APPLICATION SOFTWARE, MODEL 9990 DESKTOP SOFTWARE, MODEL 9322 PATIENT MAGNET, AND MODEL 9767/9767L TELEMETRY PROGRAMMING HEAD (TELEMETRY B). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC M DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT

510(k) clearances by this applicant