BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S048 · Decision Apr 9, 2009
    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 SYSTEM, SOF-SENSORS ON PHILLIPS BASE MODELS MMT-7002, MMT-7003
    PMA Number
    P980022
    Supplement Number
    S048
    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 9, 2009
    Date Received
    February 27, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN CHANGES TO THE MMT-7002 AND MMT-7003 GLUCOSE SENSORS MODELS AND A NEW SUPPLIER QUALIFICATION. THE DESIGN CHANGESINCLUDED AN INCREASE OF THE NEEDLE TUNNEL HEIGHT AND BASE FROM 0.034" TO 0.036" AND0.030" AND 0.031", RESPECTIVELY. THESE CHANGES WERE INTENDED TO REDUCE THE PROBABILITY OF A USER HAVING DIFFICULTY WITH REMOVING THE NEEDLE AFTER SENSOR INSERTION. FURTHER, THE CONNECTOR LEDGE OF THE SENOR BASE WAS INCREASED FROM 0.007" TO 0.011" TO REDUCE RELATIVEROTATIONAL MOTION BETWEEN THE SENSOR BASE CONNECTOR AND GST TRANSMITTER. PHILLIPS PLASTICS WAS ALSO QUALIFIED AS A NEW SUPPLIER FOR THE GLUCOSE SENSOR BASES IN THIS SUPPLEMENT. THE QUALIFICATION INCLUDED MODIFICATIONS INCLUDING MODIFICATIONS TO THENEEDLE GUARD CORE PIN, A MANUFACTURING TOOLING DEVICE. THIS DEVICE IS INTENDED TOCONTINUOUSLY RECORD INTERSTITIAL GLUCOSE LEVELS IN PERSONS WITH DIABETES MELLITUS. THISINFORMATION 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