PMA P100034S018

Device: Optune
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S018
Product code: NZK
Decision date: 2018-11-30
Classification: Stimulator, Low Electric Field, Tumor Treatment
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: Approval to update the Optune™ device labeling with the clinical outcome data from the pivotal study conducted to treat newly diagnosed glioblastoma (Long-Term EF-14).

Current openFDA PMA Record#

Device: Optune
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S018
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2018-11-30
Decision code: APPR
Date received: 2018-06-05
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to update the Optune™ device labeling with the clinical outcome data from the pivotal study conducted to treat newly diagnosed glioblastoma (Long-Term EF-14).