|
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 |
Predetermined Change Control Plan Authorized | 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: |
S018 S016 S001 S009 S010 S011 S012 S013 S014 S015 S017 S002 S003 S004 S005 S006 S007 S008 S023 S019 S020 S021 S029 S028 S036 S037 S038 S022 S031 S025 S026 S027 S030 S039 S033 S034 S035 S040 S032 |