PMA P150011S014
- Device
- Perceval Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S014
- Product code
- LWR
- Decision date
- 2019-01-08
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for labeling changes implemented to provide safety information regarding future valve in valve implantations.
Current openFDA PMA Record#
- Device
- Perceval Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P150011
- Supplement
- S014
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2019-01-08
- Decision code
- APPR
- Date received
- 2018-12-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes implemented to provide safety information regarding future valve in valve implantations.