PMA P900060S059
- Device
- Carbomedics Prosthetic Heart Valve (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S059
- Product code
- LWQ
- Decision date
- 2018-08-07
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Re-introduction of the X-Ray Computed Tomography equipment used for radiographic inspection of the CPHV Orifice component.
Current openFDA PMA Record#
- Device
- Carbomedics Prosthetic Heart Valve (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S059
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2018-08-07
- Decision code
- OK30
- Date received
- 2018-07-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Re-introduction of the X-Ray Computed Tomography equipment used for radiographic inspection of the CPHV Orifice component.