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

    Embolization Agent, Vascular

    PMA: P250003 · Supplement: S006 · Decision Apr 1, 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
    S006
    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
    April 1, 2026
    Date Received
    March 5, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    changes to the supplier of materials used in the Tyvek lid adhesive of the Embrace HES Accessory 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