BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive, Non-Adjunctive

    PMA: P120005 · Supplement: S083 · Decision Nov 1, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Sensor, Glucose, Invasive, Non-Adjunctive
    Trade Name
    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P120005
    Supplement Number
    S083
    Device Class
    FDA Class 3
    Product Code
    PQF
    Generic Name
    Sensor, glucose, invasive, non-adjunctive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 1, 2019
    Date Received
    June 27, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the protocol (PTL901895, V004), including addition of the Dexcom G6 CGM.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PQF Sensor, Glucose, Invasive, Non-Adjunctive