BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Embolization Agent, Vascular

    PMA: P250003 · Supplement: S005 · Decision Apr 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Embolization Agent, Vascular
    Trade Name
    Embrace Hydrogel Embolic System (HES)
    PMA Number
    P250003
    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
    April 2, 2026
    Date Received
    February 10, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    a new design of the vial holder component of the HES Precursor Kit packaging

    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