MODTRONIC(R) MODELS 7219/B/C/D/E AND 7202C/D/E
FDA premarket approval P900061/S021 · decided 1997-02-04
Approval details
- PMA number
- P900061
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODTRONIC(R) MODELS 7219/B/C/D/E AND 7202C/D/E
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1995-11-02
- Decision date
- 1997-02-04
- Days to decision
- 460 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ALTERNATE FIRMWARE/HARDWARE DESIGN FOR THE MEDTRONIC (R) MODELS 7219B/C/D/E AND 7202C/D/E
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