Optune System

FDA Premarket Approval P100034 S027

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 a manufacturing site, a. L. Electronics ltd, located at 24 giron abraham street, yehud, israel 56217, to manufacture the ine transducer arrays in the optune system.

DeviceOptune System
Generic NameStimulator, Low Electric Field, Tumor Treatment
ApplicantNovocure GmbH
Date Received2021-01-08
Decision Date2021-03-09
PMAP100034
SupplementS027
Product CodeNZK 
Advisory CommitteeNeurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Novocure GmbH park 6 ch-6039 Root D4 

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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07290107981545 P100034 001

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