PMA P060038S032
- Device
- Mitroflow Aortic Pericardial Heart Valve
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S032
- Product code
- LWR
- Decision date
- 2018-07-11
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Alternate gelatin supplier for use in the Carbo-Seal and Mitroflow devices.
Current openFDA PMA Record#
- Device
- Mitroflow Aortic Pericardial Heart Valve
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S032
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2018-07-11
- Decision code
- OK30
- Date received
- 2018-06-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate gelatin supplier for use in the Carbo-Seal and Mitroflow devices.