|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 PUMPS|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to a rejection criterion in the harvest of used motors during the manufacturing of refurbished pumps. The motor is a part of the insulin pump in the paradigm real-time system (mmt-522, mmt-722, mmt-522k, mmt-722k), the paradigm realtime revel system (mmt-523, mmt-723, mmt-523k, mmt-723k), and the minimed 530g system (mmt-551, mmt-751).