TRIFECTA VALVE
FDA premarket approval P100029/S018 · decided 2014-12-12
Approval details
- PMA number
- P100029
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Trade name
- TRIFECTA VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-11-13
- Decision date
- 2014-12-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- ALTERNATE BATCH SAMPLING/TESTING STRATEGY FOR BACTERIAL ENDOTOXIN TESTING (BET).
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