ST JUDE MEDICAL TRIFECTA VALVE
FDA premarket approval P100029 · decided 2011-04-20
Approval details
- PMA number
- P100029
- Trade name
- ST JUDE MEDICAL TRIFECTA VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-07-20
- Decision date
- 2011-04-20
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR THE ST. JUDE MEDICAL TRIFECTA VALVE. THE TRIFECTA VALVE IS INTENDED AS A REPLACEMENT FOR A DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC HEART VALVE.
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