|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||DEXCOM SEVEN & SEVEN PLUS SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in a manufacturing fixture used in the attachment of an adhesive patch in the sensor/ applicator delivery system component in the seven and seven plus continuous glucose monitoring systems. Additionally, the mechanical instron pull test was replaced with a manual adhesive patch pull test to be used in receiving inspection for the disposable housing of the seven and seven plus continuous glucose monitoring systems.