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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 NameNOVA TTF-100A SYSTEM
Classification Namestimulator, low electric field, tumor treatment
ApplicantNOVOCURE, INC
PMA NumberP100034
Supplement NumberS005
Date Received05/16/2013
Decision Date06/12/2013
Product Code
NZK[ Registered Establishments with NZK ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing change to the ine transducer array cable and flexible printed circuit board (pcb) of the device.
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