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

    Intracranial Aneurysm Flow Diverter

    PMA: P100018 · Supplement: S051 · Decision Jun 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Intracranial Aneurysm Flow Diverter
    Trade Name
    Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin
    PMA Number
    P100018
    Supplement Number
    S051
    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
    June 4, 2025
    Date Received
    May 9, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for sampling frequency modification for tensile testing of the pouch seal strength for the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology

    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