TRIFECTA VALVE
FDA premarket approval P100029/S014 · decided 2012-08-08
Approval details
- PMA number
- P100029
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRIFECTA VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-07-19
- Decision date
- 2012-08-08
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR ADDING AN INSPECTION FOR THE MAXIMUM LENGTH FOR CERTAIN FLAWS WHERE THE DEPTH CANNOT BE ACCURATELY ASSESSED.
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