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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 Gio
Generic NameStimulator, low electric field, tumor treatment
ApplicantNovocure, GmbH
Neuhofstrasse 21
Baar 6340
PMA NumberP100034
Supplement NumberS033
Date Received11/15/2023
Decision Date10/30/2024
Product Code NZK 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the new Optune HFE Transducer Arrays and the NovoTAL flex software, which generates layout maps for the placement of the Optune HFE Transducer Arrays on the patient's head
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