AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY & ZEPHYR PACEMAKERS
FDA premarket approval P880086/S181 · decided 2010-02-03
Approval details
- PMA number
- P880086
- Supplement
- S181
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY & ZEPHYR PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-10-02
- Decision date
- 2010-02-03
- Days to decision
- 124 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATE STERILIZATION CYCLE.
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