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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive, non-adjunctive
ApplicantDEXCOM, INC.
6340 SEQUENCE DR
SAN DIEGO, CA 92121
PMA NumberP120005
Supplement NumberS041
Date Received09/25/2015
Decision Date12/20/2016
Product Code PQF 
Docket Number 16M-4483
Notice Date 12/21/2016
Advisory Committee Clinical Chemistry
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Dexcom G5 Mobile Continuous Glucose Monitoring System (Dexcom G5) is a glucose monitoring system indicated for the management of diabetes in persons age 2 years and older. The Dexcom G5 is designed to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G5 results should be based on the glucose trends and several sequential readings over time. The Dexcom G5 also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G5 is intended for single patient use and requires a prescription.The G5 Mobile Continuous Glucose Monitoring System consists of the following devices: sensor, transmitter (with onboard algorithm), receiver, and mobile app. The sensor is a small flexible metal filament that is inserted into subcutaneous tissue where it enzymatically generates electrical current in response to the presence of glucose. The transmitter is connected to the sensor and is worn on the surface of the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The transmitter sends glucose data to both the receiver and the mobile app and receives blood glucose calibration and other user inputs from these display devices. The receiver displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 24 hours) from the transmitter. The receiver alerts the patient when glucose levels are outside of a target zone (factory set at 55 mg/dL, in addition to up to two user defined limits), when it is time to enter a blood glucose value from a fingerstick to calibrate the system, and for other important system conditions. The mobile app provides an alternative user interface to the receiver for those users with a compatible Apple iOS device. It provides similar glucose display, alert, and calibration functionality to the receiver and additionally provides connectivity to the Dexcom Share service.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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