|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||NOVOTFF-100A SYSTEM|
|Classification Name||stimulator, low electric field, tumor treatment|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the novottf-100a insulated electrode (ine) transducer array manufacturing process to improve its efficiency by automating certain manual processing steps.