BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Embolization Agent, Vascular

    PMA: P250003 · Supplement: S001 · Decision Nov 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Embolization Agent, Vascular
    Trade Name
    Embrace(TM) Hydrogel Embolic System
    PMA Number
    P250003
    Supplement Number
    S001
    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
    November 25, 2025
    Date Received
    September 11, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval to implement a minimum packaging configuration of 2 shelf boxes/shipper

    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