PMA P900060S045
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S045
- Product code
- LWQ
- Decision date
- 2011-07-13
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- ADDITION OF A NEW MOLDING SUPPLIER FOR THE MANUFACTURING OF COMPONENTS USED TO PACKAGE THE FINISHED DEVICE.
Current openFDA PMA Record#
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S045
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2011-07-13
- Decision code
- OK30
- Date received
- 2011-06-14
- Supplement type
- 30-Day Notice
- Approval order statement
- ADDITION OF A NEW MOLDING SUPPLIER FOR THE MANUFACTURING OF COMPONENTS USED TO PACKAGE THE FINISHED DEVICE.