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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 NumberS004
Date Received09/28/2026
Decision Date10/26/2026
Product Code SHC 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for changes to the sterilization load configuration.
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