BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050012 · Supplement: S010 · Decision May 25, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM STS SYSTEM
    PMA Number
    P050012
    Supplement Number
    S010
    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
    May 25, 2007
    Date Received
    April 16, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN REVISIONS TO THE ACCESSORY SOFTWARE PROGRAM TO PROVIDE ADDITIONAL SUPPLEMENTARY INFORMATION TO USERS ON GLUCOSE TRENDS AND PATTERNS DOWNLOADED TO THE PROGRAM. THE SOFTWARE PROGRAM, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCON DM2 AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS SYSTEM INTO A PERSONAL COMPUTER (PC).

    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