PMA P900060S050
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S050
- Product code
- LWQ
- Decision date
- 2012-11-05
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR ADDITION OF AN ALTERNATE SUPPLIER FOR MANUFACTURING OF THE GRAPHITE SUBSTRATE OF VALVE LEAFLETS.
Current openFDA PMA Record#
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S050
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2012-11-05
- Decision code
- APPR
- Date received
- 2012-05-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ADDITION OF AN ALTERNATE SUPPLIER FOR MANUFACTURING OF THE GRAPHITE SUBSTRATE OF VALVE LEAFLETS.