|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 PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to a supplier¿s production line for a motor part of the paradigm real-time insulin pumps (models mmt-522, mmt-522k, mmt-722, mmt-722k), paradigm real-time revel insulin pumps (models mmt-523, mmt-523k, mmt-723 and mmt-723k) and the minimed 530g insulin pumps (models mmt-551 and mmt-751). The insulin pumps are components of the paradigm real-time continuous glucose monitoring system, paradigm real-time revel continuous glucose monitoring system, and the minimed 530g system respectively.