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

    Intracranial Aneurysm Flow Diverter

    PMA: P100018 · Supplement: S053 · Decision May 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Research PMA P100018 in seconds

    The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    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
    S053
    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
    May 15, 2026
    Date Received
    April 17, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for the relocation of the Pipeline Flex and Pipeline Shield heat treatment and passivation operations from an ISO 8 Controlled Environment Area (CEA) to a Non-Controlled Area (Non-CEA) and the repositioning of the Pipeline implant braider within the Non-CEA

    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