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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® device
Generic Namestimulator, low electric field, tumor treatment
ApplicantNovocure GmbH
park 6
ch-6039 root d4 
PMA NumberP100034
Supplement NumberS029
Date Received02/14/2022
Decision Date05/10/2022
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 changes to the specifications of the ceramic discs used in the INE Transducer Arrays to make them lead-free, and the addition of a new supplier for these lead-free ceramic discs, Vishay Electronics GmbH, located at Dr.-Felix-Zandman-Platz 1, Selb 95100, Germany.