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.
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.
| Device | NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT |
| Classification Name | Stimulator, Low Electric Field, Tumor Treatment |
| Generic Name | Stimulator, Low Electric Field, Tumor Treatment |
| Applicant | Novocure, Ltd. |
| Date Received | 2010-08-16 |
| Decision Date | 2011-04-08 |
| Notice Date | 2011-05-06 |
| PMA | P100034 |
| Supplement | S |
| Product Code | NZK |
| Docket Number | 11M-0295 |
| Advisory Committee | Neurology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | Novocure, Ltd. 195 Commerce Way portsmouth, NH 03801 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100034 | Original Filing | |
| S029 | 2022-02-14 | Normal 180 Day Track |
| S028 | 2021-03-22 | Normal 180 Day Track No User Fee |
| S027 | 2021-01-08 | Normal 180 Day Track No User Fee |
| S026 | ||
| S025 | 2021-01-08 | Normal 180 Day Track No User Fee |
| S024 | ||
| S023 | 2020-02-14 | 30-day Notice |
| S022 | 2018-11-30 | Real-time Process |
| S021 | 2018-10-05 | 135 Review Track For 30-day Notice |
| S020 | 2018-09-20 | 30-day Notice |
| S019 | 2018-09-20 | Real-time Process |
| S018 | 2018-06-05 | Normal 180 Day Track |
| S017 | 2017-02-13 | 30-day Notice |
| S016 | 2016-02-17 | 30-day Notice |
| S015 | 2015-12-22 | Normal 180 Day Track |
| S014 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S013 | 2015-04-10 | Panel Track |
| S012 | 2014-09-24 | 135 Review Track For 30-day Notice |
| S011 | 2014-09-24 | 135 Review Track For 30-day Notice |
| S010 | 2014-05-30 | Normal 180 Day Track No User Fee |
| S009 | 2014-03-20 | Real-time Process |
| S008 | 2014-01-24 | Normal 180 Day Track |
| S007 | 2014-05-12 | Normal 180 Day Track |
| S006 | 2013-08-20 | 30-day Notice |
| S005 | 2013-05-16 | 30-day Notice |
| S004 | 2013-04-08 | Normal 180 Day Track |
| S003 | 2013-01-29 | Real-time Process |
| S002 | 2012-09-28 | Real-time Process |
| S001 | 2011-05-04 | Normal 180 Day Track No User Fee |