PMA P100034S041
- Device
- Optune Gio™ - Maxpoint Version 2.0
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S041
- Product code
- NZK
- Decision date
- 2025-10-23
- Classification
- Neurology
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- Approval for changes to the transducer array layout planning software MAXPOINT BR-I, including a trade name change to MAXPOINT.
Current openFDA PMA Record#
- Device
- Optune Gio™ - Maxpoint Version 2.0
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S041
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2025-10-23
- Decision code
- APPR
- Date received
- 2025-08-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the transducer array layout planning software MAXPOINT BR-I, including a trade name change to MAXPOINT.