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 modification to the field generator component of thenovottf-l00a system to replace pin: dac7614e with pin: 2ic-103572, and corresponding changes to the associated resistors and capacitors to limit the part voltage range and eliminate an observed current spike. Corresponding software changes were also made to reflect thesemodifications.
| Device | NOVOTTF-100A SYSTEM |
| Generic Name | Stimulator, Low Electric Field, Tumor Treatment |
| Applicant | Novocure GmbH |
| Date Received | 2012-09-28 |
| Decision Date | 2012-12-03 |
| PMA | P100034 |
| Supplement | S002 |
| Product Code | NZK |
| Advisory Committee | Neurology |
| Supplement Type | Real-time Process |
| 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 |