AFFINITY/INTERNITY/VICTORY FAMILY OF PACEMAKERS
FDA premarket approval P880086/S140 · decided 2007-05-09
Approval details
- PMA number
- P880086
- Supplement
- S140
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFFINITY/INTERNITY/VICTORY FAMILY OF PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-12-20
- Decision date
- 2007-05-09
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR ALTERNATE AUTOMATED TEST EQUIPMENT (ATE).
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