PMA P100034S038
- Device
- Optune® Gio
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S038
- Product code
- NZK
- Decision date
- 2024-12-18
- Classification
- Neurology
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- approval for scale-up of manufacturing processes for the Optune HFE Transducer array at the contract manufacturer
Current openFDA PMA Record#
- Device
- Optune® Gio
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S038
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2024-12-18
- Decision code
- OK30
- Date received
- 2024-11-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for scale-up of manufacturing processes for the Optune HFE Transducer array at the contract manufacturer