- Device
- Carbomedics® Prosthetic Heart Valve, Carbomedics® Supra-annular Prosthetic Heart Valve (Top Hat), Carbo-Seal® Ascending
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S064
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2022-03-07
- Decision code
- OK30
- Date received
- 2022-02-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the formulation of a detergent used to clean valve orifices and leaflets.