BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Embolization Agent, Vascular

    PMA: P220020 · Decision Apr 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Embolization Agent, Vascular
    Trade Name
    Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
    PMA Number
    P220020
    Device Class
    FDA Class 3
    Product Code
    QVG
    Generic Name
    Embolization Agent, Vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 4, 2023
    Date Received
    October 6, 2022
    Expedited Review
    N
    Docket Number
    23M-1377

    Advisory Committee Statement

    Approval for the Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit. The device is indicated for embolization of arterial hemorrhage in the peripheral vasculature.

    Classifications

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

    Product Code Device Name
    QVG Embolization Agent, Vascular