PMA P900060S048
- Device
- CARBO-SEAL AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESES
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S048
- Product code
- LWQ
- Decision date
- 2012-03-07
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- MODIFICATION TO THE LABELING ALGORITHM.
Current openFDA PMA Record#
- Device
- CARBO-SEAL AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESES
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S048
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2012-03-07
- Decision code
- OK30
- Date received
- 2012-02-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION TO THE LABELING ALGORITHM.