Mitroflow Aortic Pericardial Heart Valve
FDA premarket approval P060038/S032 · decided 2018-07-11
Approval details
- PMA number
- P060038
- Supplement
- S032
- Supplement type
- 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
- 2018-06-15
- Decision date
- 2018-07-11
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- Alternate gelatin supplier for use in the Carbo-Seal and Mitroflow devices.
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