|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||real-time process|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes to the dexcom studio¿ software: support was added for windows 8, open office, and canadian english and canadian french installations; improved system performance for large clinics that manage large numbers of patients; the word ¿blinded¿ was added to every chart when the receiver data is downloaded in ¿blinded¿ mode; the tooltip was translated into various languages; and labeling changes were made to the dexcom studio¿ software guide, g4¿ sensor manual, and receiver replacement guide.