CARBOMEDICS PROSTHETIC HEART VALVE
FDA premarket approval P900060/S023 · decided 2002-04-30
Approval details
- PMA number
- P900060
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARBOMEDICS PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2002-02-26
- Decision date
- 2002-04-30
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- APPROVAL FOR THE REMOVAL OF THE BIOLITE CARBON COATING FROM THE SEWING CUFF OF THE ABOVE REFERENCED PRODUCTS.
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