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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 Lua®
Generic NameElectrical tumor treatment fields for non-small cell lung cancer
ApplicantNovocure, GmbH
Neuhofstrasse 21
Baar 6340
PMA NumberP230042
Supplement NumberS005
Date Received12/09/2025
Decision Date01/07/2026
Product Code SDA 
Advisory Committee Anesthesiology
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  
addition of a second-source supplier (TDK) for the for the lead-free ceramic discs used with the Optune Lua ITE Transducer Arrays.
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