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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP120005
Date Received04/09/2012
Decision Date10/05/2012
Product Code
MDS[ Registered Establishments with MDS ]
Docket Number 12M-1049
Notice Date 10/12/2012
Advisory Committee Clinical Chemistry
Clinical Trials NCT01514292
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 of hyperglycemia 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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S017 S019 S020 S021 S022 
S023 S024 S025 
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