This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the optune (formerly the novottf-100a system). This device is indicated as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (gbm). Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy. Optune was previously approved in 2011 for the treatment of recurrent gbm with the following indications for use (ifu): optune is indicated following histologically-or radiologically-confirmed recurrence in the supra-tentorial 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 | OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM) |
| Classification Name | Stimulator, Low Electric Field, Tumor Treatment |
| Generic Name | Stimulator, Low Electric Field, Tumor Treatment |
| Applicant | Novocure GmbH |
| Date Received | 2015-04-10 |
| Decision Date | 2015-10-05 |
| Notice Date | 2015-11-02 |
| PMA | P100034 |
| Supplement | S013 |
| Product Code | NZK |
| Docket Number | 15M-4015 |
| Advisory Committee | Neurology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Novocure GmbH park 6 ch-6039 Root D4 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| 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 |