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

    Stent, Iliac

    PMA: P110043 · Supplement: S014 · Decision Sep 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    Omnilink Elite Vascular Balloon-Expandable Stent System
    PMA Number
    P110043
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    NIO
    Generic Name
    STENT, ILIAC
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 20, 2024
    Date Received
    September 9, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for changing the bacterial endotoxin test method from gel clot to kinetic chromogenic

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NIO Stent, Iliac