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 an additional ceramic disc supplier with no changes to electrical specifications.
| Device | Optune System |
| Classification Name | Stimulator, Low Electric Field, Tumor Treatment |
| Generic Name | Stimulator, Low Electric Field, Tumor Treatment |
| Applicant | Novocure, Ltd. |
| Date Received | 2018-10-05 |
| Decision Date | 2019-04-12 |
| PMA | P100034 |
| Supplement | S021 |
| Product Code | NZK |
| Advisory Committee | Neurology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Novocure, Ltd. 195 Commerce Way portsmouth, NH 03801 |
| 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 |