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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOptune Lua
Generic NameElectrical tumor treatment fields for non-small cell lung cancer
ApplicantNovocure, GmbH
Neuhofstrasse 21
Baar 6340
PMA NumberP230042
Date Received12/15/2023
Decision Date10/15/2024
Product Code SDA 
Docket Number 24M-5718
Notice Date 10/25/2024
Advisory Committee Anesthesiology
Clinical TrialsNCT02973789
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel is indicated for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S004 S005 
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