|Trade Name||SOF-SENSOR GLUCOSE SENSORS|
|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 the replacement of the current sof-sensor glucose sensor mmt-7002 and mmt-7003 pouch with a similar one by supplier tolas healthcare. The difference between the two pouches is that the bottom web of the pouch is changed from p/n tpf-0521 to p/n tpf-0521 nc due to the change of the supplier for tolas healthcare.