CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS
FDA premarket approval P900060/S024 · decided 2002-12-10
Approval details
- PMA number
- P900060
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2002-06-11
- Decision date
- 2002-12-10
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- APPROVAL TO COMBINE THE CARBOMEDICS PROSTHETIC HEART VALVE (CPHV; APPROVED ON SEPTEMBER 29, 1993 UNDER P900060) WITH THE SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS (CLEARED ON JUNE 13, 2002 UNDER K013022). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS, MODEL CP-(SIZE), WILL BE AVAILABLE IN SIZES 21, 23, 25, 27, 29, 31, AND 33 MM, AND IS INDICATED FOR USE IN OPEN HEART SURGERY FOR SIMULTANEOUS REPLACEMENT OF T
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