BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Injectable, Embolic

    PMA: P030004 · Decision Jul 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Agent, Injectable, Embolic
    Trade Name
    ONYX LIQUID EMBOLIC SYSTEM
    PMA Number
    P030004
    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
    July 21, 2005
    Date Received
    March 18, 2003
    Expedited Review
    N
    Docket Number
    05M-0328

    Advisory Committee Statement

    APPROVAL FOR THE ONYX LIQUID EMBOLIC SYSTEM (LES). THE DEVICE IS INDICATED FOR PRESURGICAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS.

    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