PMA P150011S011
- Device
- Perceval Sutureless Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S011
- Product code
- LWR
- Decision date
- 2018-02-08
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for a new manufacturing assembly tool and changes to the tissue sewing process.
Current openFDA PMA Record#
- Device
- Perceval Sutureless Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S011
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2018-02-08
- Decision code
- APPR
- Date received
- 2017-07-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new manufacturing assembly tool and changes to the tissue sewing process.