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U.S. Department of Health and Human Services

Devices@FDA
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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
ApplicantDexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
PMA NumberP120005
Supplement NumberS053
Date Received07/28/2016
Decision Date10/26/2016
Withdrawal Date03/20/2026
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01514292
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for modifications to the Dexcom G5 Mobile Transmitter firmware. The new transmitter firmware version comprises changes to the battery voltage limits, and correction of anomalies for a real time clock range error, firmware version display error, and an unrecoverable transmitter error at initialization. The Dexcom G5 Mobile Transmitter is a component of the Dexcom G5® Mobile Continuous Glucose Monitoring System.
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