AFFINITY/INTEGRITY/VICTORY FAMILIES OF PACEMAKERS
FDA premarket approval P880086/S168 · decided 2008-10-01
Approval details
- PMA number
- P880086
- Supplement
- S168
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFFINITY/INTEGRITY/VICTORY FAMILIES OF PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-09-02
- Decision date
- 2008-10-01
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ADDITION OF AN END OF LIFE (EL) COMMUNICATION SOFTWARE TEST TO THE AUTOMATED MANUFACTURING SOFTWARE TEST SUITE USED DURING HYBRID MANUFACTURING.
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