PMA P100034S031
- Device
- Optune System
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S031
- Product code
- NZK
- Decision date
- 2023-08-14
- Classification
- Neurology
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- Approval for a trade name change from Optune to Optune Gio.
Current openFDA PMA Record#
- Device
- Optune System
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S031
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2023-08-14
- Decision code
- APPR
- Date received
- 2023-04-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a trade name change from Optune to Optune Gio.