PMA P060038S033
- Device
- Mitroflow Aortic Pericardial Heart Valve
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S033
- Product code
- LWR
- Decision date
- 2019-11-21
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval to terminate NEMO post-approval study.
Current openFDA PMA Record#
- Device
- Mitroflow Aortic Pericardial Heart Valve
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S033
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2019-11-21
- Decision code
- APPR
- Date received
- 2019-04-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval to terminate NEMO post-approval study.