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U.S. Department of Health and Human Services

Devices@FDA
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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
Neuhofstrasse 21
Baar 6340
PMA NumberP100034
Supplement NumberS018
Date Received06/05/2018
Decision Date11/30/2018
Product Code NZK 
Advisory Committee Neurology
Clinical TrialsNCT00379470
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to update the Optune™ device labeling with the clinical outcome data from the pivotal study conducted to treat newly diagnosed glioblastoma (Long-Term EF-14).
Post-Approval StudyShow Report Schedule and Study Progress
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