MODEL 9881E SOFTWARE (9881E 217214 REVISION:C)
FDA premarket approval P900061/S019 · decided 1995-11-06
Approval details
- PMA number
- P900061
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 9881E SOFTWARE (9881E 217214 REVISION:C)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1995-08-14
- Decision date
- 1995-11-06
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODEL 9881E SOFTWARE, 9881E 217214 REVISION:C, FOR MODEL 9790 AND 9790C PROGRAMMERS WITH MODEL 7216/7217 PCD AND 7201 CD DEVICES
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