|Trade Name||GUARDIAN REAL-TIME MONITOR|
|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 to the monitor vibrator motor including conformance with rohs directive which restricts the use of hazardous materials in the manufacture of electrical and electronic products.