BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intracranial Coil-Assist Stent

    PMA: P170013 · Supplement: S002 · Decision Oct 6, 2018
    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
    S002
    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
    October 6, 2018
    Date Received
    September 6, 2018
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a revision to the Instructions for Use to add a Precaution related to the use of magnetic resonance angiography (MRA) for follow up assessment following treatment with the LVIS and LVIS Jr. devices and a revision to the symbols in the Instructions for Use and the package labeling to align these symbols with the current FDA recognized standard.

    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