|Trade Name||MINIMED 530G INSULIN PUMP|
|Classification Name||artificial pancreas device system, threshold suspend|
|Generic Name||artificial pancreas device system, threshold suspend|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|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.