PMA P150011S007
- Device
- PERCEVAL SUTURELESS HEART VALVE
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S007
- Product code
- LWR
- Decision date
- 2017-02-16
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Introduction of a template tool to facilitate leaflet height inspection and revision of the steady flow test acceptance criteria.
Current openFDA PMA Record#
- Device
- PERCEVAL SUTURELESS HEART VALVE
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S007
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2017-02-16
- Decision code
- OK30
- Date received
- 2017-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of a template tool to facilitate leaflet height inspection and revision of the steady flow test acceptance criteria.