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

    Embolization Agent, Vascular

    PMA: P250003 · Supplement: S002 · Decision Dec 17, 2025
    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
    S002
    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
    December 17, 2025
    Date Received
    November 18, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to update to the PEG percent substitution test method, the Laysan Bio Manufacturing process for PEG, and process specifications by the steam sterilization supplier, Steris

    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