BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intracranial Aneurysm Flow Diverter

    PMA: P180027 · Supplement: S011 · Decision Aug 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Intracranial Aneurysm Flow Diverter
    Trade Name
    Flow Re-Direction Endoluminal Device (FRED®) System
    PMA Number
    P180027
    Supplement Number
    S011
    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
    August 21, 2024
    Date Received
    July 22, 2024
    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) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180027/S002

    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