|Trade Name||PARADIGM REAL-TIME INSULIN PUMP|
|Classification Name||sensor, glucose, invasive|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modification to the paradigm real-time insulin pump to add an insulation pad to the pump motor flex cable and is indicated for continuous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition to delivery of insulin, the paradigm insulin pump is designed to receive and display real-time glucose values received via a compatible transmitting device.