BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S013 · Decision Apr 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL TIME SYSTEM
    PMA Number
    P980022
    Supplement Number
    S013
    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
    April 7, 2006
    Date Received
    October 4, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE MMT 515/715 EXTERNAL INSULIN PUMP AND TO THE GUARDIAN RT SENSOR TO ENABLE THE PUMP TO ACCEPT DATA FROM THE SENSOR, AND TO ENABLE THE SENSOR TO COMMUNICATE DIRECTLY TO THE PUMP. THE DEVICE WILL BE MANUFACTURED AT MEDTRONIC MINIMED, NORTHRIDGE, CALIFORNIA.

    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