SDA · Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
· Class 3
Overview
| Product Code | SDA |
|---|---|
| Device Name | Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer |
| Device Class | Class 3 |
| Review Panel | |
| Life-Sustaining | Yes |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P230042 | Optune Lua | Novocure, GmbH | Oct 15, 2024 | APPR |
Top Applicants
- Novocure, GmbH — 1 clearance
