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

    Ventricular (Assist) Bypass

    PMA: P100047 · Supplement: S031 · Decision Oct 30, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
    PMA Number
    P100047
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    DSQ
    Generic Name
    Ventricular (assist) bypass
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 30, 2013
    Date Received
    September 30, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATION OF THE IN-PROCESS VISUAL INSPECTION AND ADDITION OF A VARIABLE INSPECTION METHOD FOR TWO DEVICE COMPONENTS WHICH ARE PART OF THE HEARTWARE® VENTRICULAR ASSIST SYSTEM.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSQ Ventricular (Assist) Bypass