PMA P150011S033
- Device
- PERCEVAL SUTURELESS HEART VALVE
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S033
- Product code
- LWR
- Decision date
- 2025-10-28
- Classification
- Cardiovascular
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- implementing an alternative vaporized hydrogen peroxide generator
Current openFDA PMA Record#
- Device
- PERCEVAL SUTURELESS HEART VALVE
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S033
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2025-10-28
- Decision code
- OK30
- Date received
- 2025-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementing an alternative vaporized hydrogen peroxide generator