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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 System
Generic Namestimulator, low electric field, tumor treatment
ApplicantNovocure GmbH
park 6
ch-6039 root d4 
PMA NumberP100034
Supplement NumberS019
Date Received09/20/2018
Decision Date12/19/2018
Product Code NZK 
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to Optune System carrying case and INE Transducer Array package sizes; Optune System software modifications increasing the secondary alarm threshold for INE Transducer Array partial attachment, correcting data transfer processing following switch from battery to mains power, and eliminating a redundant INE Transducer Array overheating alarm; and NovoTerminal software modifications improving Optune System data transfer processing.