PMA P130011S006
- Device
- Solo Smart Stentless Heart Valve
- Applicant
- Corcym Canada Corp
- PMA number
- P130011
- Supplement
- S006
- Product code
- LWR
- Decision date
- 2018-03-07
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Implementation of a new sterilization and neutralization (HCSTAN) system.
Current openFDA PMA Record#
- Device
- Solo Smart Stentless Heart Valve
- Applicant
- Corcym Canada Corp
- PMA number
- P130011
- Supplement
- S006
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2018-03-07
- Decision code
- OK30
- Date received
- 2018-02-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new sterilization and neutralization (HCSTAN) system.