PMA P900060S057
- Device
- Carbomedics Prosthetic Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S057
- Product code
- LWQ
- Decision date
- 2018-05-24
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Use of automatic equipment to assess the integrity and functional characteristics of heart valves.
Current openFDA PMA Record#
- Device
- Carbomedics Prosthetic Heart Valve
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S057
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2018-05-24
- Decision code
- OK30
- Date received
- 2018-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of automatic equipment to assess the integrity and functional characteristics of heart valves.