PMA approvals

Novocure GmbH’s Optune Gio

Novocure, GmbH · Stimulator, low electric field, tumor treatment · Neurology

P100034 S045SupplementApproved
Open FDA's page for this record
PMA number
P100034
Supplement number
S045
Applicant
Novocure, GmbH
Street 1
Neuhofstrasse 21
City
Baar
Zip
6340
Generic name
Stimulator, low electric field, tumor treatment
Trade name
Novocure GmbH’s Optune Gio
Product code
NZK
Advisory committee
NE
Advisory committee description
Neurology
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited review flag
N
Date received
2026-05-18
Decision date
2026-09-18
Decision code
APPR
Ao statement
Approval for a manufacturing site located at SorVan Radiation, Ltd., Kiryat Soreq, POB 214, Yavne, 8180000, Israel for sterilization.
Harmonized identifiers (openFDA)
Device name
Stimulator, Low Electric Field, Tumor Treatment
Medical specialty description
Unknown
Device class
3
Registration number
3009453079, 3009746061, 3010291427, 3010457505, 3009306483, 3003639781, 8043792, 2032098
FEI number
3009453079, 3009746061, 3010291427, 3003058448, 3010457505, 3009306483, 3003639781, 3002808269
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.