PMA P900060S020
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S020
- Product code
- LWQ
- Decision date
- 2000-06-29
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR THE USE OF A NITINOL LOCK WIRE AS AN ALTERNATIVE MATERIAL FOR THE SEWING CUFF ATTACHMENT MECHANISM OF THE PRODUCTS LISTED.
Current openFDA PMA Record#
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S020
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2000-06-29
- Decision code
- APPR
- Date received
- 1999-07-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF A NITINOL LOCK WIRE AS AN ALTERNATIVE MATERIAL FOR THE SEWING CUFF ATTACHMENT MECHANISM OF THE PRODUCTS LISTED.