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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrical tumor treatment fields for non-small cell lung cancer
Definition 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.
Product CodeSDA
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 0 1 3 2

MDR Year MDR Reports MDR Events
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 6 6
Hypersensitivity/Allergic reaction 3 3
Hematoma 1 1
Hemoptysis 1 1
Chest Pain 1 1
Pneumonia 1 1
Convulsion/Seizure 1 1

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