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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 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
6340 sequence dr
san diego, CA 92121
PMA NumberP120005
Supplement NumberS011
Date Received09/16/2013
Decision Date06/03/2014
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM, THAT INCLUDES THE DEXCOM G4 PLATINUM PROFESSIONAL RECEIVER SHIELD, TO ALLOW MULTIPLE PATIENT USE OF THE SYSTEM BY A HEALTHCARE PROFESSIONAL. THE DEVICE, AS MODIFIED, WILL BE MARKETEDUNDER THE TRADE NAME G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED FOR:THE DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 18 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR MULTIPLE PATIENT USE AND REQUIRES PURCHASE BY A HEALTHCARE PROVIDER. THE SYSTEM IS NOT INTENDED FOR USE IN A HOSPITAL SETTING.THE DEXCOM G4 PLATINUM PROFESSIONAL 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 PROFESSIONAL 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 G4 PLATINUM PROFESSIONAL SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERALSEQUENTIAL READINGS OVER TIME.
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