BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S103 · Decision Jun 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING
    PMA Number
    P980022
    Supplement Number
    S103
    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
    June 19, 2012
    Date Received
    November 14, 2011
    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 A MANUFACTURING PROCESS CHANGE TO INCORPORATE THE ADDITION OF PROCESS WATER TO A USED BATCH OF PLATINUM PLATING SOLUTION FOR THE SOF SENSOR GLUCOSE SENSORS (MODELS MMT-7002 AND MMT-7003) THAT ARE COMPONENTS OF THE MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, THE PARADIGM REAL-TIME SYSTEM, THE GUARDIAN REAL-TIME SYSTEM, THE CGMS IPRO SYSTEM AND THE CGMS IPRO2 SYSTEM.

    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