PMA P900060S063
- Device
- Carbomedics Prosthetic Heart Valve (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S063
- Product code
- LWQ
- Decision date
- 2021-09-09
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for labeling changes which reduce risks and clearly explain how to use a newly designed accessory holder safely
Current openFDA PMA Record#
- Device
- Carbomedics Prosthetic Heart Valve (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S063
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2021-09-09
- Decision code
- APPR
- Date received
- 2021-08-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes which reduce risks and clearly explain how to use a newly designed accessory holder safely