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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Trade NameNovoTTF™-100L System
Classification Nameelectrical tumor treatment fields
Generic Nameelectrical tumor treatment fields
Applicant
Novocure, Ltd.
195 commerce way
portsmouth, NH 03801
HDE NumberH180002
Date Received10/23/2018
Decision Date05/23/2019
Product Code
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
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