|Trade Name||SOF-SENSOR GLUCOSE SENSOR|
|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 the removal of the in-process refrigeration storage requirement throughout the fabrication and assembly of the sensors.