PMA P100034S033

Device: Optune Gio
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S033
Product code: NZK
Decision date: 2024-10-30
Classification: Neurology
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: approval for the new Optune HFE Transducer Arrays and the NovoTAL flex software, which generates layout maps for the placement of the Optune HFE Transducer Arrays on the patient's head

Current openFDA PMA Record#

Device: Optune Gio
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S033
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2024-10-30
Decision code: APPR
Date received: 2023-11-15
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the new Optune HFE Transducer Arrays and the NovoTAL flex software, which generates layout maps for the placement of the Optune HFE Transducer Arrays on the patient's head