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

    Sensor, Glucose, Invasive

    PMA: P150021 · Supplement: S033 · Decision Sep 19, 2018
    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
    S033
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 19, 2018
    Date Received
    August 20, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Higher volume preparations of stock solutions used to prepare FreeStyle Libre sensors, and qualification of a new supplier for reagents used for FreeStyle Libre sensor lot release testing as well as increased shelf life for those reagents. The FreeStyle Libre sensor is a component of the FreeStyle Libre and FreeStyle Libre Pro Continuous Glucose Monitoring Systems.

    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