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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.
 
Trade NameNOVOTTF-100A SYSTEM
Classification Namestimulator, low electric field, tumor treatment
ApplicantNOVOCURE, INC
PMA NumberP100034
Supplement NumberS003
Date Received01/29/2013
Decision Date04/17/2013
Product Code
NZK[ Registered Establishments with NZK ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software modification to add an alarm to the idle loop (the non-treatment loop) to indicate that the device is still powered on even when treatment is not active.
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