MITROFLOW AORTIC PERICARDIAL HEART VALVE
FDA premarket approval P060038 · decided 2007-10-23
Approval details
- PMA number
- P060038
- Trade name
- MITROFLOW AORTIC PERICARDIAL HEART VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2006-12-18
- Decision date
- 2007-10-23
- Days to decision
- 309 days
- Decision code
- APWD
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- APPROVAL FOR THE MITROFLOW AORTIC PERICARDIAL HEART VALVE, SIZES 19, 21, 23, 25, AND 27 MM. THE DEVICE IS INTENDED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
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