FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
PMA: P230042
·
Decision Oct 15, 2024
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
- Trade Name
- Optune Lua
- PMA Number
- P230042
- Device Class
- FDA Class 3
- Product Code
- SDA
- Generic Name
- Electrical tumor treatment fields for non-small cell lung cancer
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 15, 2024
- Date Received
- December 15, 2023
- Expedited Review
- N
- Docket Number
- 24M-5718
Advisory Committee Statement
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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SDA | Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer | FDA class 3 | Unknown |