MEDTRONIC MODEL 7219B, 7219E, AND 7202E ARRYTHMIA MANAGEMENT DEVICES.
FDA premarket approval P900061/S020 · decided 1995-12-14
Approval details
- PMA number
- P900061
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC MODEL 7219B, 7219E, AND 7202E ARRYTHMIA MANAGEMENT DEVICES.
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1995-08-25
- Decision date
- 1995-12-14
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MED REL, ROAD 909, KM.0.4, BARRIO MARIANA, HUMACAO, PUERTO RICO 00661 TO MANUFACTURE THE MODELS 7219B, 7219E, AND 7202E
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