PMA P900060S056
- Device
- Carbomedics Prosthetic Heart Valve (CPHV).
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S056
- Product code
- LWQ
- Decision date
- 2017-03-03
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Change to acceptance criteria for the visual inspection of the Carbomedics Prosthetic Heart Valve orifice
Current openFDA PMA Record#
- Device
- Carbomedics Prosthetic Heart Valve (CPHV).
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S056
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2017-03-03
- Decision code
- OK30
- Date received
- 2017-02-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to acceptance criteria for the visual inspection of the Carbomedics Prosthetic Heart Valve orifice