BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P900023 · Supplement: S042 · Decision Mar 23, 2005
    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
    S042
    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
    March 23, 2005
    Date Received
    December 22, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO ONLY THE AB5000 CIRCULATORY SUPPORT SYSTEM THAT WILL ALLOW THE USER AN ALTERNATE MEANS OF REDUCING BLOOD FLOW DURING WEANING BY ADJUSTING THE LEVEL OF VACUUM APPLIED TO THE AB5000 BLOOD PUMP.

    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