BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P160054 · Supplement: S125 · Decision Jun 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    HeartMate 3™ Left Ventricular Assist System (LVAS)
    PMA Number
    P160054
    Supplement Number
    S125
    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
    June 10, 2026
    Date Received
    March 12, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for alternate connector components for the connection interface between the user interface (UI) membrane and the main printed circuit board assembly (PCBA) of the HeartMate II (HMII) System Controller and HeartMate 3 (HM3) System Controller.

    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