Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
SDA · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
SDA
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
AN
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
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.