BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intracranial Aneurysm Flow Diverter

    PMA: P180027 · Supplement: S013 · Decision Nov 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Intracranial Aneurysm Flow Diverter
    Trade Name
    Flow Re-Direction Endoluminal Device (FRED®) System
    PMA Number
    P180027
    Supplement Number
    S013
    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
    November 2, 2025
    Date Received
    May 8, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of the stent surface functionalization manufacturing process and to perform stent pusher loading, packaging, labeling, and sterilization on the FRED X system at the MicroVention Costa Rica manufacturing site located at Zona Franca Coyol Alajuela, Costa Rica.

    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