PMA P230042S005
- Device
- Optune Lua®
- Applicant
- Novocure, GmbH
- PMA number
- P230042
- Supplement
- S005
- Product code
- SDA
- Decision date
- 2026-01-07
- Classification
- Anesthesiology
- Generic name
- Electrical tumor treatment fields for non-small cell lung cancer
- Approval order statement
- addition of a second-source supplier (TDK) for the for the lead-free ceramic discs used with the Optune Lua ITE Transducer Arrays.
Current openFDA PMA Record#
- Device
- Optune Lua®
- Applicant
- Novocure, GmbH
- PMA number
- P230042
- Supplement
- S005
- Product code
- SDA
- Generic name
- Electrical tumor treatment fields for non-small cell lung cancer
- Decision date
- 2026-01-07
- Decision code
- OK30
- Date received
- 2025-12-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a second-source supplier (TDK) for the for the lead-free ceramic discs used with the Optune Lua ITE Transducer Arrays.