Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | MARQUIS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S023 |
Date Received | 10/15/2001 |
Decision Date | 03/01/2002 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MEDTRONIC MODEL 7274 MARQUIS DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 9966 (MARQUIS 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 MODEL 7274 MARQUIS DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. |
|
|