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

    Agent, Injectable, Embolic

    PMA: P030004 · Supplement: S009 · Decision Dec 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Agent, Injectable, Embolic
    Trade Name
    ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR
    PMA Number
    P030004
    Supplement Number
    S009
    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
    December 18, 2015
    Date Received
    November 18, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE ADDITION OF CLARIFICATION TO THE COATING PROCEDURE REGARDING THE TOP COAT CURING TIME AND THE INCLUSION OF AN ADDITIONAL WEIGHING BALANCE TO THE COATING PREPARATION PROCEDURE FOR THE APOLLO ONYX DELIVERY MICRO CATHETER.

    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