BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Embolization Agent, Vascular

    PMA: P220020 · Supplement: S004 · Decision Mar 20, 2025
    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
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    QVG
    Generic Name
    Embolization Agent, Vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 20, 2025
    Date Received
    February 18, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change to acceptance criteria for air and liquid leak testing of the mixing manifold

    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