PMA P100034S042

Device: Optune Gio
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S042
Product code: NZK
Decision date: 2026-06-04
Classification: Neurology
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: Approval for an additional manufacturing site, AvailMed S.A. de C.V., located at C. Industrial Lt. 001 Mz. 105, No. 20905 Int. A. Col. Cd. IndustrialTijuana, Baja California, Mexico, for the HFE Arrays in the Optune Gio system.

Current openFDA PMA Record#

Device: Optune Gio
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S042
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2026-06-04
Decision code: APPR
Date received: 2025-09-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an additional manufacturing site, AvailMed S.A. de C.V., located at C. Industrial Lt. 001 Mz. 105, No. 20905 Int. A. Col. Cd. IndustrialTijuana, Baja California, Mexico, for the HFE Arrays in the Optune Gio system.