BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intracranial Coil-Assist Stent

    PMA: P170013 · Supplement: S007 · Decision Oct 8, 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
    S007
    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 8, 2021
    Date Received
    September 8, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the revised protocol for the post-approval study (PAS).

    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