BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S127 · Decision Feb 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    IPRO2 CGM RECORDER
    PMA Number
    P980022
    Supplement Number
    S127
    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 20, 2013
    Date Received
    November 13, 2012
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MANUFACTURING CHANGES TO THE IPRO2 RECORDER COMPONENT OF THE IPRO2 CONTINUOUS GLUCOSE MONITORING SYSTEM THAT AFFECT THE SERIAL AND MODEL NUMBER ASSIGNMENT TOOL AND THE ACCURACY TESTER DEVICE LEVEL TESTER SOFTWARE.

    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