MITROFLOW AORTIC PERICARDIAL HEART VALVE
FDA premarket approval P060038/S029 · decided 2016-09-23
Approval details
- PMA number
- P060038
- Supplement
- S029
- 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
- 2016-08-11
- Decision date
- 2016-09-23
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- Approval for the addition of a new bovine tissue supplier.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.