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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameITE Transducer Array
Classification Nameelectrical tumor treatment fields
Generic Nameelectrical tumor treatment fields
Applicant
Novocure, GmbH
neuhofstrasse 21
baar 6340
HDE NumberH180002
Supplement NumberS010
Date Received04/24/2026
Decision Date06/30/2026
Product Code
QGZ[ Registered Establishments with QGZ ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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