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 a smaller, lighter weight version of the original optune™ system, referred to as the optune™ system (novottf-200a system).
| Device | OPTUNE |
| Classification Name | Stimulator, Low Electric Field, Tumor Treatment |
| Generic Name | Stimulator, Low Electric Field, Tumor Treatment |
| Applicant | Novocure GmbH |
| Date Received | 2015-12-22 |
| Decision Date | 2016-07-13 |
| PMA | P100034 |
| Supplement | S015 |
| Product Code | NZK |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Novocure GmbH park 6 ch-6039 Root D4 |
| 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 |