AFFINITY DR & DC; ENTITY DR & DC
FDA premarket approval P880086/S061 · decided 1999-06-17
Approval details
- PMA number
- P880086
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFFINITY DR & DC; ENTITY DR & DC
- Generic name
- Programmer, pacemaker
- Applicant
- ABBOTT MEDICAL
- Date received
- 1999-05-21
- Decision date
- 1999-06-17
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- KRG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval to distribute various pulse generators.
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