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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.
 
DeviceDexcom G4 PLATINUM Continuous Glucose Monitoring System, Dexcom G5 Mobile Continuous Glucose Monitoring System
Generic NameSensor, glucose, invasive
ApplicantDEXCOM, INC.
6340 SEQUENCE DR
SAN DIEGO, CA 92121
PMA NumberP120005
Supplement NumberS082
Date Received06/11/2019
Decision Date08/20/2019
Product Codes MDS PQF 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to improve drop impact resistance to the receiver component of the Dexcom G4 PLATINUM Continuous Glucose Monitoring System and Dexcom G5 Mobile Continuous Glucose Monitoring System.
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