PMA P900060S062
- Device
- CARBOMEDICS Prosthetic Heart Valve (CPHV)
- Applicant
- Corcym S.r.l.
- Product code
- LWQ
- Decision date
- 2023-01-13
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for a 3rd tier sub-supplier change for the raw PTFE felt material used in the sewing ring of the devices.
Current openFDA PMA Record#
- Device
- CARBOMEDICS Prosthetic Heart Valve (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S062
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2023-01-13
- Decision code
- APPR
- Date received
- 2021-03-04
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a 3rd tier sub-supplier change for the raw PTFE felt material used in the sewing ring of the devices.