TRIFECTA HEART VALVE
FDA premarket approval P100029/S003 · decided 2011-12-22
Approval details
- PMA number
- P100029
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRIFECTA HEART VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-05-20
- Decision date
- 2011-12-22
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR AN ADDITIONAL STERILIZATION SITE AND FOR FINAL PACKAGING OPERATIONS LOCATED AT ST. JUDE MEDICAL, PAMPULHA, BRAZIL.
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