BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intracranial Aneurysm Flow Diverter

    PMA: P170024 · Supplement: S012 · Decision May 18, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Intracranial Aneurysm Flow Diverter
    Trade Name
    Surpass Elite Flow Diverter System
    PMA Number
    P170024
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    OUT
    Generic Name
    Intracranial aneurysm flow diverter
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 18, 2024
    Date Received
    May 1, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the Surpass Elite Flow Diverter System that was developed through design modifications to the approved Surpass Evolve Flow Diverter System (P170024/S003). The design modifications consist of changes to the delivery system resheath pad and distal protection assembly, the stent braid to include a 5.25 mm diameter stent model and picks per inch specifications to be the same for all stent diameters, and manufacturing process for the stent braid and delivery system.

    Classifications

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

    Product Code Device Name
    OUT Intracranial Aneurysm Flow Diverter