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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
Neuhofstrasse 21
Baar 6340
PMA NumberP100034
Supplement NumberS035
Date Received06/26/2024
Decision Date09/24/2024
Product Code NZK 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval to adjust the capacitance specification for the ceramic discs used in the INE Transducer Arrays. The supplement also proposed to add TDK Electronics GmbH & Co. OG (TDK), located at Siemensstrasse 43, 8530 Deutschlandsberg, Austria, as an additional supplier for the lead-free ceramic discs, so that these components may be sourced from either Vishay Electronics GmbH or TDK
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