BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S039 · Decision Mar 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    MECHANICAL HEART VALVE SJM(R) MASTER SERIES (EXPANDED SEWING CUFF)
    PMA Number
    P810002
    Supplement Number
    S039
    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
    March 21, 1996
    Date Received
    September 11, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN EXPANDED VERSION OF THE ST. JUDE MEDICAL MECHANICAL HEART VALVE WITH TEFLON SEWING CUFF. THE NEW MODELS WILL BE AVAILABLE IN THE AORTIC SIZES OF 19, 21, 23, 25, 27, 29, AND 31 MM (AET-104) AND THE MITRAL SIZES OF 19, 21, 23, 25, 27, 29, 31, AND 33MM (MET-104)

    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