BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Injectable, Embolic

    PMA: P030004 · Supplement: S005 · Decision Apr 5, 2012
    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
    S005
    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 5, 2012
    Date Received
    January 26, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE AND PATIENT BROCHURE THAT STRENGTHEN THE WARNINGS ABOUT CATHETER ENTRAPMENT.

    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