510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SDAClass III

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

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FDA source (opens on fda.gov)

SDA is the FDA product code for Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SDA
Device name
Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code