MEDTRONIC MODEL 7278 MAXIMO DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND MODEL 7232 MAXIMO VR SINGLE CHAM
FDA premarket approval P980016/S042 · decided 2004-04-08
Approval details
- PMA number
- P980016
- Supplement
- S042
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- MEDTRONIC MODEL 7278 MAXIMO DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND MODEL 7232 MAXIMO VR SINGLE CHAM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2004-03-26
- Decision date
- 2004-04-08
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEDREL, JUNCOS, PUERTO RICO.
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