PMA P900060S038
- Device
- CARBOMEDICS CARBO-SEAL AND VALSALVA ASCENDING AORTIC PROSTHESIS
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S038
- Product code
- LWQ
- Decision date
- 2007-04-26
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- ADDITIONAL STERILIZER FOR STERILIZING CARBOMEDICS CARBO-SEAL AND VALSALVA ASCENDING AORTIC PROSTHESIS DEVICES.
Current openFDA PMA Record#
- Device
- CARBOMEDICS CARBO-SEAL AND VALSALVA ASCENDING AORTIC PROSTHESIS
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S038
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2007-04-26
- Decision code
- OK30
- Date received
- 2007-03-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL STERILIZER FOR STERILIZING CARBOMEDICS CARBO-SEAL AND VALSALVA ASCENDING AORTIC PROSTHESIS DEVICES.