PMA P900060S023
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S023
- Product code
- LWQ
- Decision date
- 2002-04-30
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE BIOLITE CARBON COATING FROM THE SEWING CUFF OF THE ABOVE REFERENCED PRODUCTS.
Current openFDA PMA Record#
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S023
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2002-04-30
- Decision code
- APPR
- Date received
- 2002-02-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE BIOLITE CARBON COATING FROM THE SEWING CUFF OF THE ABOVE REFERENCED PRODUCTS.