PMA P230042S001

Device: Optune Lua
Applicant: Novocure, GmbH
PMA number: P230042
Supplement: S001
Product code: SDA
Decision date: 2025-08-12
Classification: Anesthesiology
Generic name: Electrical tumor treatment fields for non-small cell lung cancer
Approval order statement: Sponsor requested approval for replacing the material used for the ITE Transducer Array’s liner component with an equivalent polyethylene terephthalate (PET) material.

Current openFDA PMA Record#

Device: Optune Lua
Applicant: Novocure, GmbH
PMA number: P230042
Supplement: S001
Product code: SDA
Generic name: Electrical tumor treatment fields for non-small cell lung cancer
Decision date: 2025-08-12
Decision code: APPR
Date received: 2025-05-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Sponsor requested approval for replacing the material used for the ITE Transducer Array’s liner component with an equivalent polyethylene terephthalate (PET) material.