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

    Intracranial Coil-Assist Stent

    PMA: P170013 · Supplement: S011 · Decision Jan 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Intracranial Coil-Assist Stent
    Trade Name
    LVIS
    PMA Number
    P170013
    Supplement Number
    S011
    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
    January 17, 2024
    Date Received
    December 18, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for manufacturing site change for the component supplier that winds platinum wire into coils for the distal tip of the delivery system pusher of the Flow Re-Direction Endoluminal Device (FRED) System and Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., and LVIS EVO

    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