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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 NameNOVOTFF-100A SYSTEM
Classification Namestimulator, low electric field, tumor treatment
ApplicantNOVOCURE, LTD.
PMA NumberP100034
Supplement NumberS007
Date Received05/21/2014
Decision Date11/12/2014
Product Code
NZK[ Registered Establishments with NZK ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the novottf-100a insulated electrode (ine) transducer array manufacturing process to improve its efficiency by automating certain manual processing steps.
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