DevicePMAs@therightstef:P120005_S028 JSONTXT 11 Projects

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 users 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 patientsdexcom 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.