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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP120005
Supplement NumberS001
Date Received12/05/2012
Decision Date01/04/2013
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Semi-automate the sub-assembly disposable seal (ds) process used in the g4 continuous glucose monitoring system. Additionally, a new clean room was added to accommodate the new disposable seal machine and provide additional manufacturing capacity for the other processes.
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