|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 STS SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for design revisions to the accessory software program to enable it to be used for consumer use. The software program, as modified will be marketed under the trade name dexcom dm-consumer and is indicated for use by consumers to allow for the transfer of glucose data stored by the dexcom sts system into a personal computer.