|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|
|Classification Name||sensor, glucose, invasive|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Use of an alternative supercapacitor due to a supply chain problem. The supercapacitor 1037110-003 (nec p/n: fgh0h154zf-h5e) will replace 1037110-002 (nec pin: fgh0h154zf-le) for the paradigm real-time insulin pump (models mmt-522, -522k, -722, -722k) and paradigm real-time revel insulin pump (models mmt -523, -523k, -723,-723k). The paradigm real-time pump is a component of the paradigm real-time continuous glucose monitoring system. The paradigm real-time revel pump is a component of the paradigm real-time revel continuous glucose monitoring system.