|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 CGM|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for 1) the addition of new components to the global transmitter/global receiver system allowing communication at 2. 4 ghz; 2) minor modifications to the applicator bail and safety card; and 3) updates to the optional data manager software that is provided with the seven plus cgm system. The device, as modified, will be marketed under the trade name dexcom color continuous glucose monitoring (cgm) system, and is a glucose-monitoring device indicated for detecting and tracking glucose trends and patterns to aid in the detection of episodes of hyperglycemia and hypoglycemia in adults with diabetes. The system is intended for single patient use and requires a prescription.