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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
park 6
ch-6039 root d4
lucerne 
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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