BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intracranial Aneurysm Flow Diverter

    PMA: P100018 · Supplement: S008 · Decision Oct 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Intracranial Aneurysm Flow Diverter
    Trade Name
    PIPELINE EMBOLIZATION DEVICE
    PMA Number
    P100018
    Supplement Number
    S008
    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
    October 22, 2013
    Date Received
    July 22, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DESIGN CHANGE FOR THE SHORTER PIPELINE¿ EMBOLIZATIONDEVICES (PED), MODEL NUMBERS FA-77XXX-XX, WITH LENGTHS BETWEEN 10MM AND 20MM. THIS DESIGN CHANGE INVOLVES REPLACING THE DELIVERY CORE WIRE CURRENTLY AVAILABLE ON THESE SHORTER PED LENGTHS (RM-00013-XX) WITH THE DELIVERY CORE WIRE CURRENTLY AVAILABLE ON THE LONGER PEDLENGTHS (RM-00089-XX), MODEL NUMBERS FA-71XXX-XX, BETWEEN 25MM AND 35MM.

    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