Mitroflow Aortic Pericardial Heart Valve
FDA premarket approval P060038/S031 · decided 2018-03-28
Approval details
- PMA number
- P060038
- Supplement
- S031
- 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
- 2017-12-26
- Decision date
- 2018-03-28
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- Approval for modifications to the molding process parameters for the Model DL and Crown PRT stent frames.
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