BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P900060 · Supplement: S024 · Decision Dec 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS
    PMA Number
    P900060
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    LWQ
    Generic Name
    HEART-VALVE, MECHANICAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 10, 2002
    Date Received
    June 11, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee 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 THE ASCENDING AORTA AND THE AORTIC VALVE IN CASES OF ANEURYSM, DISSECTION, OR OTHER DISEASE CONDITIONS OF THE AORTA COMBINED WITH DISEASE OR DEGENERATION OF THE AORTIC VALVE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWQ Heart-Valve, Mechanical