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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 G4 PLATINUM RECEIVER, G4 PLATINUM PEDIATRIC RECEIVER, DEXCOM G5 MOBILE RECEIVER, DEXCOM G4 PLATINUM RECEIVER WIT
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
PMA NumberP120005
Supplement NumberS047
Date Received04/26/2016
Decision Date07/08/2016
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 the replacement of the receiver speaker component of the Dexcom G4 PLATINUM/G5 Mobile. Together with the proposed component change, the supplement requested approval of changes to the speaker installation method. The proposed changes occur at Dexcom Inc. as well as OnCore Manufacturing Services, Dexcoms approved supplier. The receiver is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring Systems.
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