Mitroflow Aortic Pericardial Heart Valve
FDA premarket approval P060038/S033 · decided 2019-11-21
Approval details
- PMA number
- P060038
- Supplement
- S033
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Mitroflow Aortic Pericardial Heart Valve
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2019-04-08
- Decision date
- 2019-11-21
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- Approval to terminate NEMO post-approval study.
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