SDA — Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer Class III
FDA product code SDA covers "Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SDA
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- No
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.