BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P900023 · Supplement: S039 · Decision Dec 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
    PMA Number
    P900023
    Supplement Number
    S039
    Device Class
    FDA Class 3
    Product Code
    DSQ
    Generic Name
    Ventricular (assist) bypass
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 23, 2003
    Date Received
    December 15, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL LABEL IN THE FORM OF A PACKAGING STICKER STATING, "ONLY USE THREADED RESTRAINTS WITH THE AB5000 VENTRICLE. USE OF NON-THREADED CANNULA RESTRAINTS MAY RESULT IN: 1) CANNULAE BECOMING DISCONNECTED FROM THE VENTRICLE, AND 2) THROMBUS FORMATION."

    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