|Trade Name||CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS)|
|Classification Name||sensor, glucose, invasive|
|Generic Name||continuous subcutaneous glucose monitoring system|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes in the manufacturing process including replacement of centrifugation of glucose oxidase with filtration, and incorporation of keypad overlay with a new adhesive.