Optune Gio - Maxpoint Version 2.0
FDA premarket approval P100034/S041 · decided 2025-10-23
Approval details
- PMA number
- P100034
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Optune Gio - Maxpoint Version 2.0
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2025-08-08
- Decision date
- 2025-10-23
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Approval for changes to the transducer array layout planning software MAXPOINT BR-I, including a trade name change to MAXPOINT.
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