PMA P060038S028
- Device
- MITROFLOW AORTIC PERICARDIAL HEART VALVE
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S028
- Product code
- LWR
- Decision date
- 2016-07-14
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Introduction of an alternative verification test method used to verify the Isopropyl Alcohol (IPA) concentration of the sterilant solution.
Current openFDA PMA Record#
- Device
- MITROFLOW AORTIC PERICARDIAL HEART VALVE
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S028
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2016-07-14
- Decision code
- OK30
- Date received
- 2016-06-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of an alternative verification test method used to verify the Isopropyl Alcohol (IPA) concentration of the sterilant solution.