BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S073 · Decision Jun 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEV-0016 CARELINK PERSONAL SOFTWARE VERSION 1.0A
    PMA Number
    P980022
    Supplement Number
    S073
    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
    June 29, 2010
    Date Received
    May 10, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES (DEV-0016). THE SOFTWARE VERSION 1.0A IS A REVISION TO IMPLEMENT SEVERAL FEATURE ENHANCEMENTS AND CORRECTION OF THREE MINOR ANOMALIES.

    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