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

    Intracranial Aneurysm Flow Diverter

    PMA: P180027 · Supplement: S007 · Decision Mar 1, 2022
    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, FREDX System
    PMA Number
    P180027
    Supplement Number
    S007
    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
    March 1, 2022
    Date Received
    January 31, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Relocation of the supplier of several Flow Re-Direction Endoluminal Device (FRED) System and FRED X System components, Creganna Medical, from the manufacturing location in Tualatin, Oregon, to Wilsonville, Oregon, and Heredia, 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