AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
FDA premarket approval P880086/S137 · decided 2006-11-21
Approval details
- PMA number
- P880086
- Supplement
- S137
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-10-23
- Decision date
- 2006-11-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ELIMINATION OF THE EXTRA PERIMETER STAKING EPOXY AT FINAL ASSEMBLY ON THE LV HYBRID AND COVER SUPPORT INTERFACE ON ALL AFFINITY, INTEGRITY, IDENTITY, VICTORY AND FRONTIER FAMILY OF DEVICES.
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