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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceDexom G4 PLATINUM Continuous Glucose Monitoring System
Generic NameSensor, glucose, invasive
ApplicantDEXCOM, INC.
6340 SEQUENCE DR
SAN DIEGO, CA 92121
PMA NumberP120005
Supplement NumberS062
Date Received04/04/2017
Decision Date05/04/2017
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Add a transmitter printed circuit board assembly (PCBA) reset station during manufacturing of the G5 Mobile Transmitters which is a component of Dexcom G5 Mobile Continuous Glucose Monitoring System.
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