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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.
 
DeviceG5 Mobile transmitter Hardware and Firmware, G5 Mobile Continuous Glucose Monitoring System
Generic NameSensor, glucose, invasive, non-adjunctive
ApplicantDexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
PMA NumberP120005
Supplement NumberS073
Date Received04/04/2018
Decision Date07/03/2018
Withdrawal Date03/20/2026
Product Code PQF 
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 minor design changes to the Dexcom G5 transmitter hardware and firmware. The Dexcom G5 transmitter is part of the Dexcom G5 Mobile Continuous Glucose Monitoring System (CGM).
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