|Trade Name||IPRO2 CGM RECORDER|
|Classification Name||sensor, glucose, invasive|
|Generic Name||sensor, glucose, invasive|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for manufacturing changes to the ipro2 recorder component of the ipro2 continuous glucose monitoring system that affect the serial and model number assignment tool and the accuracy tester device level tester software.