BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050012 · Supplement: S039 · Decision Jul 24, 2012
    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
    S039
    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 24, 2012
    Date Received
    August 15, 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 PROPOSED CHANGE TO REMOVE REDUNDANT DESTRUCTIVE TESTING FOR BOND STRENGTH OF THREE APPLICATOR COMPONENTS (CANNULA CARRIER, PUSH ROD CARRIER, AND SENSOR NEEDLE CARRIER) OF THE DEVICES.

    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