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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)
Generic NameStimulator, low electric field, tumor treatment
ApplicantNovocure GmbH
Park 6
CH-6039 Root D4 
PMA NumberP100034
Supplement NumberS013
Date Received04/10/2015
Decision Date10/05/2015
Product Code NZK 
Docket Number 15M-4015
Notice Date 11/02/2015
Advisory Committee Neurology
Clinical TrialsNCT00916409
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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