PMA P100034

Device: Novocure GmbH’s Optune Gio
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S029
Product code: NZK
Decision date: 2026-09-18
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: Approval for a manufacturing site located at SorVan Radiation, Ltd., Kiryat Soreq, POB 214, Yavne, 8180000, Israel for sterilization.

Current openFDA PMA Record#

Device: Novocure GmbH’s Optune Gio
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S045
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2026-09-18
Decision code: APPR
Date received: 2026-05-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at SorVan Radiation, Ltd., Kiryat Soreq, POB 214, Yavne, 8180000, Israel for sterilization.