BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Agent, Injectable, Embolic

    PMA: P030004 · Supplement: S012 · Decision Jan 25, 2017
    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
    S012
    Device Class
    FDA Class 3
    Product Code
    MFE
    Generic Name
    Agent, injectable, embolic
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 25, 2017
    Date Received
    December 27, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Acceptance for manufacturing equipment/process changes related to the production of the Onyx Liquid Embolic System (LES), which include addition of an alternative cleaning and de-pyrogenation method for the Onyx LES, addition of an alternative dry heat sterilization oven for the Onyx LES, and change of bioburden testing lab for the Onyx vial subassembly.

    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