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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 Pax®
Generic NameLow Electric Field Generator for Pancreatic Cancer Treatment
ApplicantNovocure, GmbH
Neuhofstrasse 21
Baar 6340
PMA NumberP250034
Supplement NumberS001
Date Received04/24/2026
Decision Date07/01/2026
Product Code SHC 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for extending the shelf life of the sterilized ITE transducer array from nine months to twelve months.
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