MITROFLOW AORTIC PERICARDIAL HEART VALVE
FDA premarket approval P060038/S004 · decided 2009-08-28
Approval details
- PMA number
- P060038
- Supplement
- S004
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MITROFLOW AORTIC PERICARDIAL HEART VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2009-05-27
- Decision date
- 2009-08-28
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- APPROVAL FOR THE ADDITION OF A NEW BOVINE PERICARDIUM SUPPLIER USED IN THE MANUFACTURE OF THE DEVICE.
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