MARQUIS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA premarket approval P980016/S023 · decided 2002-03-01
Approval details
- PMA number
- P980016
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MARQUIS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-10-15
- Decision date
- 2002-03-01
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- 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 VENTR
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