PMA P230042S002
- Device
- Optune Lua
- Applicant
- Novocure, GmbH
- PMA number
- P230042
- Supplement
- S002
- Product code
- SDA
- Decision date
- 2025-06-04
- Classification
- Anesthesiology
- Generic name
- Electrical tumor treatment fields for non-small cell lung cancer
- Approval order statement
- addition of a second supplier for the thermistor component of the ITE Transducer Arrays
Current openFDA PMA Record#
- Device
- Optune Lua
- Applicant
- Novocure, GmbH
- PMA number
- P230042
- Supplement
- S002
- Product code
- SDA
- Generic name
- Electrical tumor treatment fields for non-small cell lung cancer
- Decision date
- 2025-06-04
- Decision code
- OK30
- Date received
- 2025-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a second supplier for the thermistor component of the ITE Transducer Arrays