Optune Lua
FDA premarket approval P230042/S002 · decided 2025-06-04
Approval details
- PMA number
- P230042
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Optune Lua
- Generic name
- Electrical tumor treatment fields for non-small cell lung cancer
- Applicant
- Novocure, GmbH
- Date received
- 2025-05-21
- Decision date
- 2025-06-04
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- SDA
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Baar
- Statement
- addition of a second supplier for the thermistor component of the ITE Transducer Arrays
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