Optune Gio
FDA premarket approval P100034/S034 · decided 2024-07-12
Approval details
- PMA number
- P100034
- Supplement
- S034
- 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
- 2024-06-14
- Decision date
- 2024-07-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- the addition of a second supplier for the thermistor component of the INE Transducer Arrays
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