PMA P100034S036

Device: Optune Gio
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S036
Product code: NZK
Decision date: 2025-02-04
Classification: Neurology
Generic name: Stimulator, low electric field, tumor treatment
Approval order 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.

Current openFDA PMA Record#

Device: Optune Gio
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S036
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2025-02-04
Decision code: APPR
Date received: 2024-11-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.