Optune System

Stimulator, Low Electric Field, Tumor Treatment

FDA Premarket Approval P100034 S021

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 an additional ceramic disc supplier with no changes to electrical specifications.

DeviceOptune System
Classification NameStimulator, Low Electric Field, Tumor Treatment
Generic NameStimulator, Low Electric Field, Tumor Treatment
ApplicantNovocure, Ltd.
Date Received2018-10-05
Decision Date2019-04-12
PMAP100034
SupplementS021
Product CodeNZK
Advisory CommitteeNeurology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Novocure, Ltd. 195 Commerce Way portsmouth, NH 03801

Supplemental Filings

Supplement NumberDateSupplement Type
P100034Original 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

NIH GUDID Devices

Device IDPMASupp
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07290107981699 P100034 001
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07290107981545 P100034 001

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