Optune Lua
FDA premarket approval P230042/S001 · decided 2025-08-12
Approval details
- PMA number
- P230042
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Optune Lua
- Generic name
- Electrical tumor treatment fields for non-small cell lung cancer
- Applicant
- Novocure, GmbH
- Date received
- 2025-05-16
- Decision date
- 2025-08-12
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- SDA
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Baar
- Statement
- Sponsor requested approval for replacing the material used for the ITE Transducer Arrays liner component with an equivalent polyethylene terephthalate (PET) material.
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