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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
Generic NameStimulator, low electric field, tumor treatment
ApplicantNovocure GmbH
Park 6
CH-6039 Root D4 
PMA NumberP100034
Supplement NumberS032
Date Received07/25/2023
Decision Date02/02/2024
Product Code NZK 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval for a manufacturing site located at United States (U.S.) Operation Center II (USOC II), Novocure Inc., 2555 USA Parkway, Suite 104A, Sparks, Nevada 89437, that will perform the activities of receipt, cleaning, acceptance, storage, service, packaging, labeling and release for distribution of the Optune treatment kit.
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