Optune Lua®
FDA premarket approval P230042/S004 · decided 2025-10-08
Approval details
- PMA number
- P230042
- Supplement
- S004
- 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
- 2025-09-11
- Decision date
- 2025-10-08
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- SDA
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Baar
- Statement
- introduction of a 15 array/box packaging configuration and a 5 array/box packaging configuration, in addition to the currently approved 20 array/box configuration, for the ITE arrays at Novocures contract manufacturer Integra
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