|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|
|Classification Name||sensor, glucose, invasive|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a labeling change to the errata sheet to provide additional information about potential water damage to the paradigm real-time insulin pumps (models: mmt-522, mmt-522k, mmt-722 and mmt-722k) and the paradigm real-time revel insulin pumps (models: mmt-523, mmt-523k, mmt-723 and mmt-723k).