|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|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modification to the field generator component of the novottf-l00a system to replace pin: dac7614e with pin: 2ic-103572, and corresponding changes to the associated resistors and capacitors to limit the part voltage range and eliminate an observed current spike. Corresponding software changes were also made to reflect these modifications.