MEDTRONIC MARQUIS DR 7274.MARQUIS VR 7230,MAXIMO DR 7278,MAXIMO VR 7232
FDA premarket approval P980016/S038 · decided 2003-10-23
Approval details
- PMA number
- P980016
- Supplement
- S038
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MARQUIS DR 7274.MARQUIS VR 7230,MAXIMO DR 7278,MAXIMO VR 7232
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2003-10-07
- Decision date
- 2003-10-23
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR BATTERY CHANGES TO THE CHI 4420L BATTERY IN THE MEDTRONIC MARQUIS DR MODEL 7274, MARQUIS VR MODEL 7230, MAXIMO DR MODEL 7278, MAXIMO VR MODEL 7232, INSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289.
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