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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 NameOptune Lua
Classification Nameelectrical tumor treatment fields
Generic Nameelectrical tumor treatment fields
Applicant
Novocure, GmbH
neuhofstrasse 21
baar 6340
HDE NumberH180002
Supplement NumberS001
Date Received12/30/2019
Decision Date03/13/2020
Product Code
QGZ[ Registered Establishments with QGZ ]
Advisory Committee Anesthesiology
Clinical Trials NCT02397928
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 a proposed labeling change, specifically changing the trade name of the device from “novottftm-100l system” to “optune luatm”.
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