BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P970002 · Decision Sep 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    MONOSTRUT CARDIAC VALVE PROSTHESIS
    PMA Number
    P970002
    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
    September 30, 1997
    Date Received
    January 24, 1997
    Expedited Review
    N
    Docket Number
    98M-0200

    Advisory Committee Statement

    Approval for the Monostrut(TM) Cardiac Valve Prosthesis. This device is indicated for the replacement of malfunctioning native or prosthetic mitral (sizes 27, 29, 31, and 33 mm) or aortic (sizes 21, 23, 25, 27, 29, 31, and 33 mm) heart valves.

    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