PMA P900060S044
- Device
- CARBOMEDICS/CARBO-SEAL ASCENDING & VALSALVA/ORBIS/OPTIFORM HEART VALVES
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S044
- Product code
- LWQ
- Decision date
- 2011-06-30
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- THE ADDITION OF A NEW OPTICAL OGP SMARTSCOPE SYSTEM TO AN EXISTING COMPONENT INSPECTION.
Current openFDA PMA Record#
- Device
- CARBOMEDICS/CARBO-SEAL ASCENDING & VALSALVA/ORBIS/OPTIFORM HEART VALVES
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S044
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2011-06-30
- Decision code
- OK30
- Date received
- 2011-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- THE ADDITION OF A NEW OPTICAL OGP SMARTSCOPE SYSTEM TO AN EXISTING COMPONENT INSPECTION.