BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S036 · Decision Nov 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES
    PMA Number
    P810002
    Supplement Number
    S036
    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
    November 28, 1995
    Date Received
    May 5, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A ROTATABLE VERSION OF THE ST.JUDE MEDICAL MECHANICAL HEART VALVE - THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME:ST. JUDE MEDICAL MASTER SERIES AND WILL BE AVAILABLE IN THE FOLLOWING MODEL NUMBERS AND SIZES:AJ-501 AND AECJ-502 (19, 21, 23, 25, 27, 29, AND 31 MM), MJ-501 AND MECJ-502 (19, 21, 23, 25, 27, 29, 31, AND 33MM) AND AHPJ-505, MHPJ-505, AEJPJ-506, AND MEHPJ-506 (17, 19, 21, 23, 25, AND 27MM). THE SUPPLEMENT ALSO INCLUDES A VALVE HOLDER/ROTATOR ACCESSORY WHICH WILL BE INCLUDED AS A COMPONENT OF THE MECHANICAL HEART VALVE SIZER SET MODEL 905

    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