PMA P900060S049
- Device
- CARBOMEDICS PROSTHETIC HEART VLAVE
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S049
- Product code
- LWQ
- Decision date
- 2012-09-10
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL TO ADD NEW EQUIPMENT TO THE PYROLYTIC CARBON COATING PROCESS.
Current openFDA PMA Record#
- Device
- CARBOMEDICS PROSTHETIC HEART VLAVE
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S049
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2012-09-10
- Decision code
- APPR
- Date received
- 2012-03-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO ADD NEW EQUIPMENT TO THE PYROLYTIC CARBON COATING PROCESS.