|
Device | NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT |
Generic Name | Stimulator, low electric field, tumor treatment |
Applicant | Novocure GmbH Park 6 CH-6039 Root D4 |
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 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S025 S026 S027 S028 S029 S031 |