|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||PARADIGUM REAL TIME PUMP; PARADIGUM REAL TIME REVEL INSULIN PUMP|
|Classification Name||sensor, glucose, invasive|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of labeling changes to the user guide and to the two package inserts (errata sheets) for the paradigm real-time insulin pumps (models mmt-522, mmt-522k, mmt-722, and mmt-722k), and for the paradigm real-time revel insulin pumps (models mmt-523, mmt-523k, mmt-723, and mmt-723k). The paradigm real-time insulin pumps are components of the paradigm real-time system and the paradigm real-time revel insulin pumps are components of the paradigm real-time revel systems.