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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOPTUNE
Generic Namestimulator, low electric field, tumor treatment
ApplicantNovocure GmbH
park 6
ch-6039 root d4 
PMA NumberP100034
Supplement NumberS015
Date Received12/22/2015
Decision Date07/13/2016
Product Code NZK 
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a smaller, lighter weight version of the original Optune™ System, referred to as the Optune™ System (NovoTTF-200A System).
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