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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.
 
DeviceDEXCOM CGM
Generic NameSensor, glucose, invasive
ApplicantDEXCOM, INC.
5555 OBERLIN DR
SAN DIEGO, CA 92121
PMA NumberP050012
Supplement NumberS045
Date Received02/21/2012
Decision Date08/17/2012
Withdrawal Date 08/28/2015
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR 1) THE ADDITION OF NEW COMPONENTS TO THE GLOBAL TRANSMITTER/GLOBAL RECEIVER SYSTEM ALLOWING COMMUNICATION AT 2.4 GHZ; 2) MINOR MODIFICATIONS TO THE APPLICATOR BAIL AND SAFETY CARD; AND 3) UPDATES TO THE OPTIONAL DATA MANAGER SOFTWARE THAT IS PROVIDED WITH THE SEVEN PLUS CGM SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM COLOR CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM, AND IS A GLUCOSE-MONITORING DEVICE INDICATED FOR DETECTING AND TRACKING GLUCOSE TRENDS AND PATTERNS TO AID IN THEDETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA IN ADULTS WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.
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