|Trade Name||MINIMED 530G INSULIN PUMPS|
|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: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Transfer of purchasing, receiving, and incoming inspection activities of certain external insulin pump components used in the manufacture of the paradigm real-time pump series and the minimed 530g series from the medtronic minimed northridge facility to the medtronic puerto rico operations company and fedex/3pl facilities in puerto rico. The paradigm real쳌]time family of insulin pumps and the minimed 530g insulin pump are components of the paradigm real-time/real-time revel systems and the minimed 530g system, respectively.