AFFINITY/ENTITY DR,DC,SR
FDA premarket approval P880086/S066 · decided 1999-07-27
Approval details
- PMA number
- P880086
- Supplement
- S066
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFFINITY/ENTITY DR,DC,SR
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1999-07-06
- Decision date
- 1999-07-27
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for minor modifications to the firmware of the Affinity series of pulse generators.
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