PMA P060038S025
- Device
- MITROFLOW AORTIC PERICARDIAL HEART VALVE
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S025
- Product code
- LWR
- Decision date
- 2015-10-12
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- APPROVAL FOR EXTENDING THE SHELF LIFE FOR THE DEVICE FROM ONE YEAR TOTWO YEARS.
Current openFDA PMA Record#
- Device
- MITROFLOW AORTIC PERICARDIAL HEART VALVE
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S025
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2015-10-12
- Decision code
- APPR
- Date received
- 2015-09-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR EXTENDING THE SHELF LIFE FOR THE DEVICE FROM ONE YEAR TOTWO YEARS.