|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 PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Manufacturing change to semi-automate the assembly and ultraviolet bonding process for the cannula carrier (mt9754-01), pushrod carrier (mt9755-01) and needle carrier (mt9576-02) assemblies used in the sensor applicator component of the device.