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

    Sensor, Glucose, Invasive

    PMA: P150021 · Supplement: S005 · Decision Apr 26, 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
    S005
    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
    April 26, 2017
    Date Received
    March 30, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Update the Applicator Sub-Assembly manufacturing process from a manual to an automated process, and to update the Applicator Sub-Assembly drawing to include three updates to quality attributes for measurement checks to provide an additional control for the automated manufacturing process. The Applicator Sub-Assembly is a component of the Sensor Applicator for the Abbott Diabetes Care 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