PMA P900060S066
- Device
- Carbomedics Prosthetic Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S066
- Product code
- LWQ
- Decision date
- 2024-04-09
- Classification
- Cardiovascular
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- use of digital radiography as an alternate automatized method for the existing analog X-ray quality control testing of the leaflets
Current openFDA PMA Record#
- Device
- Carbomedics Prosthetic Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S066
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2024-04-09
- Decision code
- OK30
- Date received
- 2024-03-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- use of digital radiography as an alternate automatized method for the existing analog X-ray quality control testing of the leaflets