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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
Generic NameStimulator, low electric field, tumor treatment
ApplicantNovocure, GmbH
Neuhofstrasse 21
Baar 6340
PMA NumberP100034
Date Received08/16/2010
Decision Date04/08/2011
Product Code NZK 
Docket Number 11M-0295
Notice Date 05/06/2011
Advisory Committee Neurology
Clinical TrialsNCT00379470
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 S014 S017 S025 S026 S027 S028 S029 S036 S037 
S038 S039 S018 S019 S020 S021 S032 S043 S041 S044 S002 S011 
S012 S015 S010 S007 S013 S008 S004 S005 S022 S023 S006 S042 
S009 S030 S031 S040 S034 S035 S033 S016 
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