PMA P900060S035
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC/ VALSALVA ASCENDING AORTIC PROSTHESIS
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S035
- Product code
- LWQ
- Decision date
- 2006-01-13
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- CHANGE IN THE FELTING PROCESS OF THE PTFE FELT FILTER.
Current openFDA PMA Record#
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC/ VALSALVA ASCENDING AORTIC PROSTHESIS
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S035
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2006-01-13
- Decision code
- OK30
- Date received
- 2005-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE FELTING PROCESS OF THE PTFE FELT FILTER.