PMA P060038S031
- Device
- Mitroflow Aortic Pericardial Heart Valve
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S031
- Product code
- LWR
- Decision date
- 2018-03-28
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for modifications to the molding process parameters for the Model DL and Crown PRT stent frames.
Current openFDA PMA Record#
- Device
- Mitroflow Aortic Pericardial Heart Valve
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S031
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2018-03-28
- Decision code
- APPR
- Date received
- 2017-12-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for modifications to the molding process parameters for the Model DL and Crown PRT stent frames.