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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.
 
DeviceG4 PLATINUM Continuous Glucose Monitoring System and G5 Mobile Continuous Glucose Monitoring System
Generic NameSensor, glucose, invasive
ApplicantDEXCOM, INC.
6340 SEQUENCE DR
SAN DIEGO, CA 92121
PMA NumberP120005
Supplement NumberS078
Date Received09/07/2018
Decision Date10/04/2018
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  
Extending the relative humidity excursion period for the Dexcom G4 PLATINUM/G5 Mobile Sensor. The proposed change seeks to extend the allowable relative humidity excursion period for the sensor component in its primary packaging. The Dexcom G4 PLATINUM/G5 Mobile Sensor is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring System, respectively.
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