BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S024 · Decision Feb 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P980022
    Supplement Number
    S024
    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
    February 8, 2008
    Date Received
    December 17, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SOFTWARE MODIFICATIONS, A DESIGN CHANGE TO THE PARADIGM REAL-TIME PUMP (MODEL MMT-522, 722), AND A CHANGE TO THE STORAGE AND SHIPPING TEMPERATURE OF THE GLUCOSE SENSOR (MMT-7002C, D, E). SOFTWARE MODIFICATIONS INCLUDED UPDATING THE GUARDIAN REAL-TIME MONITOR (CSS7100) SOFTWARE TO VERSION 2.0A AND UPDATING THE CARELINK ONLINE (MMT-7333) SOFTWARE TO VERSION 4.1. THE DESIGN CHANGE TO THE PARADIGM REAL TIME PUMP INVOLVES A REDESIGN OF THE MOTOR FLEX ASSEMBLY TO INCREASE DURABILITY OF THE FLEXPRINT CONNECTOR. THE CHANGE TO THE GLUCOSE SENSOR SHIPPING AND STORAGE CONDITIONS INCLUDES AN EXPANSION OF THE TEMPERATURE RANGE TO 2-27 DEGREES C AND ALLOWS WAREHOUSE-TO-CUSTOMER SHIPPING AT NON-REFRIGERATED TEMPERATURES. THIS DEVICE IS INTENDED TO CONTINUOUSLY RECORD INTERSTITIAL GLUCOSE LEVELS IN PERSONS WITH DIABETES MELLITUS. THIS INFORMATION IS INTENDED TO SUPPLEMENT, NOT REPLACE, BLOOD GLUCOSE INFORMATION OBTAINED USING A STANDARD HOME GLUCOSE-MONITORING DEVICES. THIS INFORMATION MAY ALLOW IDENTIFICATION OF PATTERNS OF GLUCOSE LEVEL EXCURSIONS ABOVE OR BELOW THE DESIRED RANGE, FACILITATING THERAPY ADJUSTMENTS WHICH MAY MINIMIZE THESE EXCURSIONS.

    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