|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||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the insulin pump case assembly manufacturing process at medtronic puerto rico operations co. (mproc) to receive pump cases directly from a supplier with a new keypad and overlay. The insulin pumps are components of the paradigm real-time system, paradigm real-time revel system, and minimed 530g system.