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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 NumberS002
Date Received05/21/2025
Decision Date06/04/2025
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 supplier for the thermistor component of the ITE Transducer Arrays
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