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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 G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDEXCOM, INC.
6340 SEQUENCE DR
SAN DIEGO, CA 92121
PMA NumberP120005
Supplement NumberS033
Date Received02/25/2015
Decision Date08/19/2015
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR CHANGES TO THE DEXCOM TRANSMITTER AND RECEIVER AND THE ADDITION OF THE DEXCOM G5 MOBILE APP, TO ENABLE THE TRANSMISSION OF CGM DATA TO THE RECEIVER AND/OR COMPATIBLE APPLE MOBILE DEVICES, AND TO ALLOW ENTRY OF SYSTEM CALIBRATION INFORMATION DIRECTLY FROM COMPATIBLE APPLE MOBILE DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED AS FOLLOWS:THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING SYSTEM INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 2 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION. THE DEXCOM G5 MOBILE SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G5 MOBILE 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 G5 MOBILE SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
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