Optune System

Stimulator, Low Electric Field, Tumor Treatment

FDA Premarket Approval P100034 S019

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.

Pre-market Approval Supplement Details

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.

DeviceOptune System
Classification NameStimulator, Low Electric Field, Tumor Treatment
Generic NameStimulator, Low Electric Field, Tumor Treatment
ApplicantNovocure, Ltd.
Date Received2018-09-20
Decision Date2018-12-19
PMAP100034
SupplementS019
Product CodeNZK
Docket NumberPremarket 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 CommitteeNeurology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Novocure, Ltd. 195 Commerce Way portsmouth, NH 03801

Supplemental Filings

Supplement NumberDateSupplement Type
P100034Original Filing
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

NIH GUDID Devices

Device IDPMASupp
07290107983365 P100034 001
07290107980289 P100034 001
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07290107981545 P100034 001

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