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

    Intracranial Coil-Assist Stent

    PMA: P180031 · Supplement: S004 · Decision Feb 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Intracranial Coil-Assist Stent
    Trade Name
    Neuroform Atlas® Stent System
    PMA Number
    P180031
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    QCA
    Generic Name
    Intracranial coil-assist stent
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 7, 2022
    Date Received
    January 12, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Three changes to the non-patient contacting introducer sheath component of the Neuroform Atlas Stent System: 1) sheath manufacturing to be outsourced to an external supplier; 2) change from a three- to two-step manufacturing process; and 3) tip length specification simplification and change of the nominal length.

    Classifications

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

    Product Code Device Name
    QCA Intracranial Coil-Assist Stent