BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S060 · Decision Nov 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    ST JUDE MEDICAL MECHANICAL HEART VALVE
    PMA Number
    P810002
    Supplement Number
    S060
    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 21, 2007
    Date Received
    October 23, 2006
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE SUPPLIER OF THE POLYESTER YARN THAT IS USED IN THE FABRICATION OF: 1) THE KNITTED POLYESTER TUBULAR FABRIC THAT IS THE SOURCE MATERIAL FROM THE ST. JUDE MEDICAL MECHANICAL HEART VALVE SEWING CUFFS, AND 2) THE HEMASHIELD BOVINE COLLAGEN SEALED WOVEN POLYESTER VASCULAR GRAFT.

    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