|Trade Name||DEXCOM SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Generic Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Alternate vendor and method of manufacture of the disposable seal component of the applicator assembly of the seven and seven plus systems. The proposed change applies only to the disposable seal supplier and the method of manufacture; neither the materials nor the final design of the disposable seal are altered. Sensor performance and release specification will also remain unchanged.