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U.S. Department of Health and Human Services

Product Classification
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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.
Physical State Comprised of an electric field generator and insulated transducer arrays.
Technical Method Transducer arrays are placed on the patient’s chest which produce alternating electrical fields within the body. These electrical fields physically disrupt the rapid cell division of cancer cells.
Target Area Chest/Lungs
Review Panel Anesthesiology
Product CodeSDA
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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