|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.|
|Classification Name||stimulator, low electric field, tumor treatment|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a trade name change from the novottf-100a system to optune¿. You have also requested that the components of the novottf-100a system (a plugin power supply; charger for portable batteries; device & battery carrying bag; portable battery; and, connection cable & box), along with the transducer array and electric field generator (the device), be named the optune¿ treatment kit.