PMA P100034S043
- Device
- Optune Gio®
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S043
- Product code
- NZK
- Decision date
- 2026-02-25
- Classification
- Neurology
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- Approval for an additional servicing supplier for components of the device.
Current openFDA PMA Record#
- Device
- Optune Gio®
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S043
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2026-02-25
- Decision code
- OK30
- Date received
- 2026-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional servicing supplier for components of the device.