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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 NameSEVEN PLUS CONTINOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP050012
Supplement NumberS001
Date Received06/19/2006
Decision Date05/31/2007
Product Code
MDS[ Registered Establishments with MDS ]
Docket Number 07M-0255
Notice Date 06/28/2007
Advisory Committee Clinical Chemistry
Supplement Typepanel track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the sts-7 continuous glucose monitoring system (sts-7 system). The device is indicated for the following: the sts-7 continuous glucose monitoring system (sts-7 system) is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The sts-7 system is intended for use by patients at home and in health care facilities. The device is for prescription use only. The sts-7 continuous glucose monitoring system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The sts-7 continuous glucose monitoring 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 sts-7 system results should be based on the trends and patterns seen with several sequential readings over time.
Approval Order Approval Order
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