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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 HFE Transducer Arrays
Generic NameStimulator, low electric field, tumor treatment
ApplicantNovocure, GmbH
Neuhofstrasse 21
Baar 6340
PMA NumberP100034
Supplement NumberS046
Date Received08/27/2026
Decision Date09/16/2026
Product Code NZK 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval to implement a minor change to the pallet configuration for the maximum load during gamma sterilization process for the HFE arrays performed at Steris Schweiz
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