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

    Intracranial Aneurysm Flow Diverter

    PMA: P170024 · Supplement: S005 · Decision Nov 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Intracranial Aneurysm Flow Diverter
    Trade Name
    Surpass Evolve Flow Diverter System
    PMA Number
    P170024
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    OUT
    Generic Name
    Intracranial aneurysm flow diverter
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 17, 2020
    Date Received
    October 26, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Automate the application of the hydrophilic coating on the Surpass Evolve Flow Diverter 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