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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 and G5 Mobile Continuous Glucose Monitoring Systems
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
PMA NumberP120005
Supplement NumberS071
Date Received02/27/2018
Decision Date03/27/2018
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  
Removal of redundant inspection of the skived wire component, which will be processed further to manufacture the finished sensor probes. The sensors are components of the Dexcom G4 PLATINUM and Dexcom G5 Mobile Continuous Monitoring Systems.
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