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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameNOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT
Classification Namestimulator, low electric field, tumor treatment
ApplicantNOVOCURE, LTD.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 
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