BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P160035 · Supplement: S049 · Decision Sep 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    EXCOR Cannula Clip
    PMA Number
    P160035
    Supplement Number
    S049
    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
    September 12, 2025
    Date Received
    March 17, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the EXCOR Cannula Clip

    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