BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S041 · Decision Sep 4, 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
    PMA Number
    P810002
    Supplement Number
    S041
    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 4, 1996
    Date Received
    March 7, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW STERILE PACKAGE SYSTEM FOR ALL OF THE ST. JUDE MEDICAL MECHANICAL HEART VALVE MODELS, AS DESCRIBED IN ATTACHMENT 1 OF YOUR SUBMISSION

    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