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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 Namestimulator, low electric field, tumor treatment
PMA NumberP100034
Supplement NumberS002
Date Received10/15/2012
Decision Date12/03/2012
Product Code
NZK[ Registered Establishments with NZK ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product 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.