|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 TREATMENT KIT|
|Classification Name||stimulator, low electric field, tumor treatment|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to replace the current tyvek pouch packaging material for the ine transducer arrays with an aluminum foil moisture barrier and to extend the shelf life for these transducer arrays from 6 to 9 months.