- Device
- Carbomedics Prosthetic Heart Valve, Carbo-Seal Ascending Aortic Prosthesis, Carbo-Seal Valsalva Ascending Aortic Prosthe
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S061
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2020-09-17
- Decision code
- APPR
- Date received
- 2020-07-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the Optimization of Quality Control activities by removing duplicate QC inspections during manufacturing process.