FDA product code SDA: Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
SDA is the FDA product code for electrical tumor treatment fields for non-small cell lung cancer. It is a Class III device, reviewed by the Anesthesiology panel. Devices under SDA reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer |
| Device class | Class III |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for SDA devices
openFDA lists no recalls for product code SDA.
Frequently asked questions
What is FDA product code SDA?
SDA is the FDA product code for electrical tumor treatment fields for non-small cell lung cancer. It is a Class III device, reviewed by the Anesthesiology panel.
What device class is SDA?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SDA
- Run a recall and safety report across every SDA manufacturer
- Watch product code SDA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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