BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intracranial Coil-Assist Stent

    PMA: P170013 · Supplement: S005 · Decision Sep 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Intracranial Coil-Assist Stent
    Trade Name
    Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
    PMA Number
    P170013
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    QCA
    Generic Name
    Intracranial coil-assist stent
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 16, 2021
    Date Received
    March 30, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the LVIS X and LVIS Jr. X that contains a novel polymer surface treatment to the neurovascular coil-assist stent.

    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