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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 G4® PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDEXCOM, INC.
6340 SEQUENCE DR
SAN DIEGO, CA 92121
PMA NumberP120005
Supplement NumberS002
Date Received02/19/2013
Decision Date02/03/2014
Product Code MDS 
Docket Number 14M-0224
Notice Date 02/24/2014
Advisory Committee Clinical Chemistry
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS DEVICE IS INDICATED FOR:THE DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS AGES 2 TO 17 YEARS WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.THE DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES.THE DEXCOM G4 PLATINUM (PEDIATRIC) 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 G4 PLATINUM (PEDIATRIC) 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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