BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Neurovascular Liquid Embolic Agent

    PMA: P030004 · Supplement: S035 · Decision Dec 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Neurovascular Liquid Embolic Agent
    Trade Name
    Onyx Liquid Embolic System (LES)
    PMA Number
    P030004
    Supplement Number
    S035
    Device Class
    FDA Class 3
    Product Code
    SGU
    Generic Name
    Neurovascular Liquid Embolic Agent
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 8, 2025
    Date Received
    October 15, 2024
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Onyx Liquid Embolic System (LES) is indicated for embolization of the middle meningeal artery (MMA) as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma (SDH).

    Classifications

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

    Product Code Device Name
    SGU Neurovascular Liquid Embolic Agent