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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 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.
 
DeviceSEVEN PLUS CONTINOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDEXCOM, INC.
5555 OBERLIN DR
SAN DIEGO, CA 92121
PMA NumberP050012
Supplement NumberS001
Date Received06/19/2006
Decision Date05/31/2007
Withdrawal Date 08/28/2015
Product Code MDS 
Docket Number 07M-0255
Notice Date 06/28/2007
Advisory Committee Clinical Chemistry
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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