APS-11 MODEL 3003 PROGRAMMER
FDA premarket approval P880086/S011 · decided 1991-09-16
Approval details
- PMA number
- P880086
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- APS-11 MODEL 3003 PROGRAMMER
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1991-04-15
- Decision date
- 1991-09-16
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
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