BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P790018 · Supplement: S036 · Decision Nov 9, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    MEDTRONIC HALL PROSTHETIC HEART VALVE
    PMA Number
    P790018
    Supplement Number
    S036
    Device Class
    FDA Class 3
    Product Code
    LWQ
    Generic Name
    HEART-VALVE, MECHANICAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 9, 2000
    Date Received
    October 17, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ALTERNATE SUPPLIER FOR THE POLYTETRAFLUOROETHYLENE (PTFE) FABRIC CONSTRUCTED OF PTFE YARN. THIS FABRIC IS USED TO MANUFACTURE THE SEWING RING COMPONENT FOR THE MEDTRONIC HALL PROSTHETIC HEART VALVE, MODEL A7700, SIZES 20, 22, AND 24 MM.

    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