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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 NumberS080
Date Received01/22/2019
Decision Date03/15/2019
Withdrawal Date03/20/2026
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01514292
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for changes to the interim analysis.
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