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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 CONTINUOUS MONITORING SYSTEM, DEXCOM SHARE SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDEXCOM, INC.
6340 SEQUENCE DR
SAN DIEGO, CA 92121
PMA NumberP120005
Supplement NumberS028
Date Received09/12/2014
Decision Date01/23/2015
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  
FOR THE ADDITION OF A BLUETOOTH LOW ENERGY (BLE) RADIO TO BOTH THEADULT (MT20649) AND PEDIATRIC (MT22430) VERSIONS OF THE DEXCOM G4 PLATINUM RECEIVER,IDENTIFIED AS THE DEXCOM G4 PLATINUM RECEIVER WITH SHARE (ADULT - MT22495, PEDIATRIC -MT22608), AND FOR A MODIFICATION TO THE DEXCOM SHARE SYSTEM (STA-GL-400) ALLOWING THEDEXCOM G4 PLATINUM RECEIVER WITH SHARE TO COMMUNICATE DIRECTLY WITH THE DEXCOM SHARE2MOBILE APPLICATION INSTALLED ON A USER¿S APPLE MOBILE DEVICE. THE DEXCOM RECEIVER WITH SHAREIS A COMPONENT OF THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, THEDEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE DEXCOMSHARE SYSTEM. THOUGH THE INDICATIONS FOR USE FOR THE DEXCOM G4 PLATINUM CONTINUOUSGLUCOSE MONITORING SYSTEM AND THE DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSEMONITORING SYSTEM ARE UNCHANGED BY THIS SUPPLEMENT, THE DEXCOM SHARE SYSTEM, AS MODIFIED,WILL BE MARKETED UNDER THE TRADE NAME DEXCOM SHARE SYSTEM AND IS INDICATED FOR:THE PURPOSE OF DEXCOM SHARE IS TO NOTIFY ANOTHER PERSON, THE FOLLOWER, OF THE PATIENT¿SDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM SENSOR GLUCOSEINFORMATION. DEXCOM SHARE PROVIDES SECONDARY NOTIFICATION AND DOES NOT REPLACE REAL TIMECONTINUOUS GLUCOSE MONITORING (G4 PLATINUM SYSTEM) OR STANDARD HOME BLOOD GLUCOSEMONITORING.
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