PMA P150011S020
- Device
- Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S020
- Product code
- LWR
- Decision date
- 2020-06-11
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for labeling changes related to sizing instructions for the Perceval Sutureless Heart Valve.
Current openFDA PMA Record#
- Device
- Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S020
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2020-06-11
- Decision code
- APPR
- Date received
- 2020-03-16
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes related to sizing instructions for the Perceval Sutureless Heart Valve.