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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.
 
DeviceDexcon G5 Mobile Continuous Glucose Monitoring System
Generic NameSensor, glucose, invasive, non-adjunctive
ApplicantDexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
PMA NumberP120005
Supplement NumberS065
Date Received07/10/2017
Decision Date09/21/2017
Withdrawal Date03/20/2026
Product Code PQF 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for firmware modifications to the touchscreen receiver in the Dexcom G5 Mobile Glucose Monitoring System.
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