MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
FDA premarket approval P060038/S012 · decided 2012-10-09
Approval details
- PMA number
- P060038
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2012-04-12
- Decision date
- 2012-10-09
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- APPROVAL FOR THE DEVICE.
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