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

    Sensor, Glucose, Invasive

    PMA: P050012 · Supplement: S036 · Decision Mar 2, 2011
    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 CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P050012
    Supplement Number
    S036
    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
    March 2, 2011
    Date Received
    January 31, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ALTERNATE VENDOR AND METHOD OF MANUFACTURE OF THE DISPOSABLE SEAL COMPONENT OF THE APPLICATOR ASSEMBLY OF THE SEVEN AND SEVEN PLUS SYSTEMS. THE PROPOSED CHANGE APPLIES ONLY TO THE DISPOSABLE SEAL SUPPLIER AND THE METHOD OF MANUFACTURE; NEITHER THE MATERIALS NOR THE FINAL DESIGN OF THE DISPOSABLE SEAL ARE ALTERED. SENSOR PERFORMANCE AND RELEASE SPECIFICATION WILL ALSO REMAIN UNCHANGED.

    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