BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Embolization Agent, Vascular

    PMA: P220020 · Supplement: S005 · Decision Sep 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Embolization Agent, Vascular
    Trade Name
    Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
    PMA Number
    P220020
    Supplement Number
    S005
    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
    September 3, 2025
    Date Received
    March 17, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a contract manufacturing site located in Wilmington, Massachusetts and to change the legal manufacturer address

    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