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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 CONTIUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
PMA NumberP120005
Supplement NumberS056
Date Received10/11/2016
Decision Date11/16/2016
Withdrawal Date03/20/2026
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01514292
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Two changes that include an improvement to the G5 Mobile/G4 PLATINUM Transmitter machining process that reduces machining time and to introduce a new visual inspection tool. Both changes apply to G4 PLATINUM and G5 Mobile Transmitters. The Dexcom G5 Mobile/G4 PLATINUM Transmitter is a component of the Dexcom G5 Mobile and the G4 Platinum Continuous Glucose Monitoring System, respectively.
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