PMA P230042
- Device
- Optune Lua®
- Applicant
- Novocure, GmbH
- PMA number
- P230042
- Supplement
- S008
- Product code
- SDA
- Decision date
- 2026-07-01
- Classification
- Anesthesiology
- Generic name
- Electrical tumor treatment fields for non-small cell lung cancer
- Approval order statement
- approval for extending the shelf life of the sterilized ITE transducer array from nine months to twelve months.
Current openFDA PMA Record#
- Device
- Optune Lua®
- Applicant
- Novocure, GmbH
- PMA number
- P230042
- Supplement
- S008
- Product code
- SDA
- Generic name
- Electrical tumor treatment fields for non-small cell lung cancer
- Decision date
- 2026-07-01
- Decision code
- APPR
- Date received
- 2026-04-24
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for extending the shelf life of the sterilized ITE transducer array from nine months to twelve months.