BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S031 · Decision Mar 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL-TIME INSULIN INFUSINO PUMPS
    PMA Number
    P980022
    Supplement Number
    S031
    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
    March 10, 2010
    Date Received
    August 6, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE SOFTWARE MODIFICATIONS FOR MODEL MMT-523, MMT-723, MMT-523K, AND MMT-723K PARADIGM REAL-TIME INSULIN PUMPS AS WELL AS NEW VERSIONS OF CARELINK PRO AND CARELINK PERSONAL ACCESSORY SOFTWARE THAT HAVE BEEN UPDATED TO SUPPORT THESE INSULIN PUMP MODELS.

    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