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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 CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
PMA NumberP120005
Supplement NumberS038
Date Received08/10/2015
Decision Date11/06/2015
Withdrawal Date03/20/2026
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01514292
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE PACKAGING DESIGN FOR THE SENSOR/ APPLICATOR FOR THE G4 PLATINUM CGM SYSTEM AND THE MANUFACTURING LINE FOR THIS NEW PACKAGING.
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