MODEL 3037A FUNCTION PACK
FDA premarket approval P880086/S012 · decided 1991-12-24
Approval details
- PMA number
- P880086
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3037A FUNCTION PACK
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1991-04-23
- Decision date
- 1991-12-24
- Days to decision
- 245 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
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