Optune Gio
FDA premarket approval P100034/S037 · decided 2024-12-10
Approval details
- PMA number
- P100034
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Optune Gio
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2024-11-12
- Decision date
- 2024-12-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- an additional manufacturer for the sub assembly component of the INE Transducer Arrays
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