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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 G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; DEXCON G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
PMA NumberP120005
Supplement NumberS039
Date Received09/23/2015
Decision Date10/23/2015
Withdrawal Date03/20/2026
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01514292
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
REMOVAL OF AN IN-PROCESS INSPECTION TESTING PERFORMED DURING THE MANUFACTURING PROCESS OF THE G4 PLATINUM AND G5 MOBILE TRANSMITTERS. THE G4 PLATINUM AND THE G5 MOBILE TRANSMITTERS ARE COMPONENTS OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM AND G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM, RESPECTIVELY.
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