BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intracranial Aneurysm Flow Diverter

    PMA: P100018 · Supplement: S029 · Decision Apr 29, 2021
    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
    PMA Number
    P100018
    Supplement Number
    S029
    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
    April 29, 2021
    Date Received
    November 23, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the inclusion of radial access considerations in the Pipeline Flex Embolization Device labeling.

    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