|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||PARADIGM REAL-TIME REVEL INSULIN PUMP|
|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 software changes to the paradigm real-time revel insulin pump (mmt-523, mmt-523k, mmt-723, and mmt-723k) application software. These changes include corrections for two motor error anomalies and enhancements for the threshold suspend feature, insulin value setting, and merged common code base. The paradigm real-time revel insulin pump is a component of the paradigm real-time revel system.