Premarket Approval (PMA)

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.

• Device: NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT
• Generic Name: Stimulator, low electric field, tumor treatment
• Applicant: Novocure GmbH; Neuhofstrasse 21; Baar 6340
• PMA Number: P100034
• Date Received: 08/16/2010
• Decision Date: 04/08/2011
• Product Code: 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 Study: Show Report Schedule and Study Progress
• Supplements: S001 S015 S004 S006 S013 S007 S008 S010 S002 S009 S011 S012 ; S005 S014 S016 S017 S030 S031 S034 S035 S018 S019 S020 S021 ; S022 S023 S028 S029 S025 S026 S027 S032 S037 S038 S033 S003 ;