PMA P130011S002
- Device
- SOLO SMART STENTLESS HEART VALVE (SOLO SMART)
- Applicant
- Corcym Canada Corp
- PMA number
- P130011
- Supplement
- S002
- Product code
- LWR
- Decision date
- 2016-02-09
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for a change to the sterility testing of the final storage solution.
Current openFDA PMA Record#
- Device
- SOLO SMART STENTLESS HEART VALVE (SOLO SMART)
- Applicant
- Corcym Canada Corp
- PMA number
- P130011
- Supplement
- S002
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2016-02-09
- Decision code
- APPR
- Date received
- 2015-12-07
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the sterility testing of the final storage solution.