BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050012 · Supplement: S043 · Decision Jan 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM SEVEN & SEVEN PLUS SYSTEM
    PMA Number
    P050012
    Supplement Number
    S043
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 18, 2012
    Date Received
    December 21, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN A MANUFACTURING FIXTURE USED IN THE ATTACHMENT OF AN ADHESIVE PATCH IN THE SENSOR/APPLICATOR DELIVERY SYSTEM COMPONENT IN THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS. ADDITIONALLY, THE MECHANICAL INSTRON PULL TEST WAS REPLACED WITH A MANUAL ADHESIVE PATCH PULL TEST TO BE USED IN RECEIVING INSPECTION FOR THE DISPOSABLE HOUSING OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.

    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