- Device
- Carbomedics Prosthetic Heart Valve, Carbomedics Supra-Annular Prosthetic Heart Valve (Top Hat), Carbo-Seal Ascending Aor
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S067
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2024-07-09
- Decision code
- OK30
- Date received
- 2024-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new scanning electron microscope equipment to be used as an alternative to the current equipment for existing quality control testing to increase manufacturing flow efficiency