BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Injectable, Embolic

    PMA: P030004 · Supplement: S003 · Decision Oct 9, 2007
    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
    Supplement Number
    S003
    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
    October 9, 2007
    Date Received
    September 24, 2007
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISION OF THE PRODUCT LABEL TO INCLUDE A BOXED WARNING REGARDING THE EMISSION OF SPARKS THAT OCCURS WHEN ONYX-EMBOLIZED TISSUE IS SURGICALLY RESECTED WITH MONOPOLAR ELECTROCAUTERY DEVICES.

    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