PMA P130011S009
- Device
- Solo Smart Heart Valve
- Applicant
- Corcym Canada Corp
- PMA number
- P130011
- Supplement
- S009
- Product code
- LWR
- Decision date
- 2020-04-03
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Extend the maximum shipping time between abattoirs and the manufacturing site for bovine tissue from 48 hours to 96 hours.
Current openFDA PMA Record#
- Device
- Solo Smart Heart Valve
- Applicant
- Corcym Canada Corp
- PMA number
- P130011
- Supplement
- S009
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2020-04-03
- Decision code
- OK30
- Date received
- 2020-03-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extend the maximum shipping time between abattoirs and the manufacturing site for bovine tissue from 48 hours to 96 hours.