|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||GUARDIAN REAL-TIME MONITOR, MODEL CSS7100. CS7100K|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for minor software modifications in guardian® real-time system to optimize the shutdown procedure for the guardian monitor and to correct an anomaly that allowed access of out-of-bounds pointer errors.