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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received10/23/2018
Decision Date05/23/2019
Product Code
QGZ[ Registered Establishments with QGZ ]
Docket Number 19M-2522
Notice Date 05/24/2019
Advisory Committee Anesthesiology
Clinical Trials NCT02397928
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the novottf™-100l system. This device is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (mpm) to be used concurrently with pemetrexed and platinum-based chemotherapy.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 
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