PMA P150011S025
- Device
- Perceval Sutureless Heart Valve and Perceval PLUS Sutureless Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S025
- Product code
- LWR
- Decision date
- 2022-07-28
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Decrease in the number of samples used in the Limulus Amoebocyte Lysate testing performed per sterilization batch.
Current openFDA PMA Record#
- Device
- Perceval Sutureless Heart Valve and Perceval PLUS Sutureless Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S025
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2022-07-28
- Decision code
- OK30
- Date received
- 2022-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Decrease in the number of samples used in the Limulus Amoebocyte Lysate testing performed per sterilization batch.