PMA P900060S053
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S053
- Product code
- LWQ
- Decision date
- 2014-02-20
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- MODIFIED IN-PROCESS INSPECTION FOR DETECTION OF MATERIAL DEPOSITS.
Current openFDA PMA Record#
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S053
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2014-02-20
- Decision code
- OK30
- Date received
- 2014-01-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFIED IN-PROCESS INSPECTION FOR DETECTION OF MATERIAL DEPOSITS.