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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 Continuous Glucose Monitoring System, G6 Continuous Glucose Monitoring System, G7 Continuous Glucose Monitorin
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
PMA NumberP120005
Supplement NumberS091
Date Received11/15/2023
Decision Date01/09/2024
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 updates to the protocol (PTL901895, V006), including addition of the Dexcom G7 CGM.
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