|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||NOVOTTF-100A SYSTEM|
|Classification Name||stimulator, low electric field, tumor treatment|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for software modification to add an alarm to the idle loop (the non-treatment loop) to indicate that the device is still powered on even when treatment is not active.