|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Modification to the transmitter (part # 9438) holding fixture used during manufacture of the g4 platinum continuous glucose monitoring (cgm) system, dexcom g4 platinum pediatric cgm system, and the dexcom share system.