BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    PMA: P160030 · Supplement: S007 · Decision Feb 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
    Trade Name
    Freestyle Libre Flash Glucose Monitoring System
    PMA Number
    P160030
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    PZE
    Generic Name
    Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 26, 2018
    Date Received
    December 1, 2017
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for design changes to the puck carrier, applicator cap, and container tray of the Freestyle Libre Flash Glucose Monitoring System and Freestyle Libre Pro Flash Glucose Monitoring System, as well as manufacturing changes in increase production capacity for the same components.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated