BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P150021 · Supplement: S004 · Decision May 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM
    PMA Number
    P150021
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 31, 2017
    Date Received
    December 16, 2016
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval to increase the sensor manufacturing capacity, at the manufacturing facility ADC Witney, by implementing a high volume sensor manufacturing line setup. The change included updates to the printed flex circuit processing equipment, qualification of a new ISO 8 cleanroom, implementation of new manufacturing and support equipment, and introduction of a new sampling machine. The sensor is a component of the Freestyle Libre Pro Flash Glucose Monitoring System.

    Classifications

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

    Product Code Device Name
    MDS Sensor, Glucose, Invasive