BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P900060 · Supplement: S068 · Decision May 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V
    PMA Number
    P900060
    Supplement Number
    S068
    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
    May 15, 2025
    Date Received
    February 14, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for the introduction of a new supplier of PET fabric, sewing changes impacting the cuff component of CPHV devices, and the removal of the Carbofilm coating from PET fabric

    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