BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intracranial Aneurysm Flow Diverter

    PMA: P100018 · Supplement: S044 · Decision Apr 25, 2024
    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 with Shield Technology™ (PED2), Pipeline™ Vantage Embolization Device with Shield Tec
    PMA Number
    P100018
    Supplement Number
    S044
    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 25, 2024
    Date Received
    January 26, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for labeling changes [Directions for Use and Magnetic Resonance Imaging (MRI) Card] to the Pipeline Flex Embolization Device with Shield Technology and Pipeline Vantage Embolization Device with Shield Technology to incorporate more comprehensive MRI safety information

    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