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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 STS CONTINOUS MONITORS
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP050012
Date Received03/23/2005
Decision Date03/24/2006
Product Code
MDS[ Registered Establishments with MDS ]
Docket Number 06M-0200
Notice Date 05/12/2006
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the dexcom sts continuous glucose monitoring system. The device is indicated for the following: 1) indicated for detecting trends and tracking patterns in adults (18 and older) with diabetes and is intended for use by patients at home and in health care facilities. The device is for prescription use. 2) indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. 3) 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 system results should be based on the trends and patterns seen with several sequential sensor readings over time.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S024 S025 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S041 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 
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