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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
ApplicantNovocure GmbH
Park 6
CH-6039 Root D4 
PMA NumberP100034
Supplement NumberS022
Date Received11/30/2018
Decision Date02/28/2019
Product Code NZK 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a color change to the INE Transducer Array medical tape from white to tan, and a change to the release liner of the INE Transducer Array from a paper-based material to polyester.
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