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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
Applicant
Novocure GmbH
park 6
ch-6039 root d4 
PMA NumberP100034
Supplement NumberS025
Date Received01/08/2021
Decision Date03/09/2021
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 Product No
Approval Order Statement 
Approval for a manufacturing site, Flex-Romania, located at Calea Torontalului, DN 6, Km 5,7, Timisoara, Romania 300668 to manufacture the INE Transducer Arrays in the Optune System.
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