BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050012 · Supplement: S025 · Decision Jul 15, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM SEVEN AND SEVEN PLUS SYSTEM
    PMA Number
    P050012
    Supplement Number
    S025
    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 15, 2010
    Date Received
    June 15, 2010
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE DEVICE LABELING TO INCLUDE MORE EMPHASIS ON THE ALERT TO USERS ABOUT THE POTENTIAL FOR THE TIPS OF SENSORS BREAKING OFF AND TO PROVIDE RECOMMENDATIONS TO USERS REGARDING THEIR ACTIONS SHOULD THIS OCCUR.

    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