BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S028 · Decision Jul 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    CGMS IPRO SYSTEM
    PMA Number
    P980022
    Supplement Number
    S028
    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
    July 17, 2008
    Date Received
    May 19, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MMT-7319 SOLUTIONS SOFTWARE FOR CGMS IPRO CONTINUOUS GLUCOSE RECORDER TO DOWNLOAD BLOOD GLUCOSE METER VALUES, OR MANUAL ENTRY OF BLOOD GLUCOSE VALUES, FROM THE LIFESCAN ULTRA 2 AND LIFESCAN ULTRALINK METERS, IN ADDITION TO THE PARADIGM LINK, LIFESCAN ULTRA AND FREESTYLE FLASH METERS.

    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