PMA P100034S013

Device

OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)

Applicant

Novocure, GmbH

PMA number

P100034

Supplement

S013

Product code

NZK

Decision date

2015-10-05

Classification

Stimulator, Low Electric Field, Tumor Treatment

Generic name

Stimulator, low electric field, tumor treatment

Approval order statement

APPROVAL FOR THE OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM). THIS DEVICE IS INDICATED AS A TREATMENT FOR ADULT PATIENTS (22 YEARS OF AGE OR OLDER) WITH HISTOLOGICALLY-CONFIRMED GLIOBLASTOMA MULTIFORME (GBM). OPTUNE WITH TEMOZOLOMIDE IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED, SUPRATENTORIAL GLIOBLASTOMA FOLLOWING MAXIMAL DEBULKING SURGERY AND COMPLETION OF RADIATION THERAPY TOGETHER WITH CONCOMITANT STANDARD OF CARE CHEMOTHERAPY. OPTUNE WAS PREVIOUSLY APPROVED IN 2011 FOR THE TREATMENT OF RECURRENT GBM WITH THE FOLLOWING INDICATIONS FOR USE (IFU): OPTUNE IS INDICATED FOLLOWING HISTOLOGICALLY-OR RADIOLOGICALLY-CONFIRMED RECURRENCE IN THE SUPRA-TENTORIAL REGION OF THE BRAIN AFTER RECEIVING CHEMOTHERAPY. THE DEVICE IS INTENDED TO BE USED AS A MONOTHERAPY, AND IS INTENDED AS AN ALTERNATIVE TO STANDARD MEDICAL THERAPY FOR GBM AFTER SURGICAL AND RADIATION OPTIONS HAVE BEEN EXHAUSTED.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100034S013B.pdf" target="_new">Summary of Safety and Effectiveness</a>