Optune Gio
FDA premarket approval P100034/S033 · decided 2024-10-30
Approval details
- PMA number
- P100034
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Optune Gio
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2023-11-15
- Decision date
- 2024-10-30
- Days to decision
- 350 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- approval for the new Optune HFE Transducer Arrays and the NovoTAL flex software, which generates layout maps for the placement of the Optune HFE Transducer Arrays on the patient's head
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