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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT
Classification Namestimulator, low electric field, tumor treatment
Generic Namestimulator, low electric field, tumor treatment
Applicant
Novocure GmbH
park 6
ch-6039 root d4 
PMA NumberP100034
Date Received08/16/2010
Decision Date04/08/2011
Product Code
NZK[ Registered Establishments with NZK ]
Docket Number 11M-0295
Notice Date 05/06/2011
Advisory Committee Neurology
Clinical Trials NCT00379470
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
APPROVAL FOR THE NOVOTTF-100A SYSTEM. THE DEVICE IS INDICATED FOR TREATMENT OF ADULT PATIENTS (22 YEARS OF AGE OR OLDER) WITH HISTOLOGICALLY- CONFIRMED GLIOBLASTOMA MULTIFORME, FOLLOWING HISTOLOGICALLY- OR RADIOLOGICALLY- CONFIRMED RECURRENCE IN THE SUPRATENTORIAL 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 
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