BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Injectable, Embolic

    PMA: P030004 · Supplement: S040 · Decision Apr 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Agent, Injectable, Embolic
    Trade Name
    Onyx™ Liquid Embolic System (LES)
    PMA Number
    P030004
    Supplement Number
    S040
    Device Class
    FDA Class 3
    Product Code
    MFE
    Generic Name
    Agent, injectable, embolic
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 29, 2026
    Date Received
    January 30, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the mixing time, packaging configuration, and sterilization process for the Onyx Liquid Embolic System (LES).

    Classifications

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

    Product Code Device Name
    MFE Agent, Injectable, Embolic