|Trade Name||CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSOR MMT-7002|
|Classification Name||sensor, glucose, invasive|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the modifications of the coating process from the spin coating process to the slot coating process, and the adhesion promoter (ap) solution.