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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Generic Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
6340 sequence dr
san diego, CA 92121
PMA NumberP120005
Date Received04/09/2012
Decision Date10/05/2012
Product Code MDS 
Docket Number 12M-1049
Notice Date 10/12/2012
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01514292
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS DEVICE IS INDICATED FOR:THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 18 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.THE DEXCOM G4 PLATINUM SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G4 PLATINUM SYSTEM AIDS IN THE DETECTION OF EPISODES OFHYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE DEXCOM G4 PLATINUM SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S046 S047 S048 S049 S050 
S051 S052 S053 S055 S056 S057 S058 S059 S060 S061 S062 S063 
S064 S065 S066 S067 S068 S069 S071 S073 S074 S075 S076 S077 
S078 S079 S080 S081 S082 S083 S086 S087 S088 S089 
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