Optune Gio
FDA premarket approval P100034/S036 · decided 2025-02-04
Approval details
- PMA number
- P100034
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Optune Gio
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2024-11-07
- Decision date
- 2025-02-04
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Approval to assemble the Optune Gio device and its battery using the plastic enclosure components which are currently used to assemble the Optune Lua device and its battery.
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