BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050012 · Supplement: S018 · Decision May 5, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM SEVEN SYSTEMS
    PMA Number
    P050012
    Supplement Number
    S018
    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 5, 2009
    Date Received
    March 9, 2009
    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 DEXCOM DATA MANAGER 3 (DM3) AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS OR SEVEN SYSTEMS INTO A PERSONAL COMPUTER (PC). THE SOFTWARE MODIFICATIONS INCLUDED SEVERAL NEW FEATURES AS IDENTIFIED IN THE SUBMISSION.

    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