|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 INSULIN PUMPS;PARADIGM REAL-TIME REVEL INSULIN PUMPS|
|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 the reduction of keypad button (dome) sizes, new keypad overlay supplier (bergquist), and keypad/ overlay/ case assembly process for the paradigm real-time insulin pumps (models: mmt-522, mmt-522k, mmt-722, mmt-722k and paradigm real-time revel insulin pumps (models: mmt-523, mmt-523k, mmt-723, and mmt-723k) that are components of the paradigm real-time and paradigm real-time revel systems, respectively.