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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 NumberS001
Date Received05/16/2025
Decision Date08/12/2025
Product Code SDA 
Advisory Committee Anesthesiology
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  
Sponsor requested approval for replacing the material used for the ITE Transducer Array’s liner component with an equivalent polyethylene terephthalate (PET) material.
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