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 changes to optune system carrying case and ine transducer array package sizes; optune system software modifications increasing the secondary alarm threshold for ine transducer array partial attachment, correcting data transfer processing following switch from battery to mains power, and eliminating a redundant ine transducer array overheating alarm; and novoterminal software modifications improving optune system data transfer processing.
Device | Optune System |
Classification Name | Stimulator, Low Electric Field, Tumor Treatment |
Generic Name | Stimulator, Low Electric Field, Tumor Treatment |
Applicant | Novocure, Ltd. |
Date Received | 2018-09-20 |
Decision Date | 2018-12-19 |
PMA | P100034 |
Supplement | S019 |
Product Code | NZK |
Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
Advisory Committee | Neurology |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
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 |