PMA P230042S004

Device: Optune Lua®
Applicant: Novocure, GmbH
PMA number: P230042
Supplement: S004
Product code: SDA
Decision date: 2025-10-08
Classification: Anesthesiology
Generic name: Electrical tumor treatment fields for non-small cell lung cancer
Approval order 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 Novocure’s contract manufacturer Integra

Current openFDA PMA Record#

Device: Optune Lua®
Applicant: Novocure, GmbH
PMA number: P230042
Supplement: S004
Product code: SDA
Generic name: Electrical tumor treatment fields for non-small cell lung cancer
Decision date: 2025-10-08
Decision code: OK30
Date received: 2025-09-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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 Novocure’s contract manufacturer Integra