Optune System

FDA Premarket Approval P100034 S023

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

To move certain assembly activities performed for the optune system from one building to another at the approved contract manufacturer's site

DeviceOptune System
Generic NameStimulator, Low Electric Field, Tumor Treatment
ApplicantNovocure GmbH
Date Received2020-02-14
Decision Date2020-03-15
PMAP100034
SupplementS023
Product CodeNZK 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess 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
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
07290107980357 P100034 001
07290107980401 P100034 001
07290107980715 P100034 001
07290107981484 P100034 001
07290107981491 P100034 001
07290107981507 P100034 001
07290107981514 P100034 001
07290107981521 P100034 001
07290107981538 P100034 001
07290107981569 P100034 001
07290107980234 P100034 001
07290107980197 P100034 001
07290107983389 P100034 001
07290107983396 P100034 001
07290107980708 P100034 001
07290107980692 P100034 001
07290000000003 P100034 001
07290107981699 P100034 001
07290000000005 P100034 001
07290000000007 P100034 001
07290107981781 P100034 001
07290107980029 P100034 001
07290107980098 P100034 001
07290107981576 P100034 001
07290107981590 P100034 001
07290107982016 P100034 001
07290107982030 P100034 001
07290107982047 P100034 001
07290107982078 P100034 001
07290107982207 P100034 001
07290107982214 P100034 001
07290107982221 P100034 001
07290107982474 P100034 001
07290107982481 P100034 001
07290107982498 P100034 001
07290107981545 P100034 001
07290107981767 P100034 001
07290107981750 P100034 001
07290107981606 P100034 001
07290107981613 P100034 001
07290107981637 P100034 001
07290107981644 P100034 001
07290107981651 P100034 001
07290107981668 P100034 001
07290107981675 P100034 001
07290107981682 P100034 001
07290107981712 P100034 001
07290107981729 P100034 001
07290107981743 P100034 001
07290107981545 P100034 001

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.