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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceNOVOCURE'S OPTUNE SYSTEM
Generic Namestimulator, low electric field, tumor treatment
Applicant
Novocure GmbH
park 6
ch-6039 root d4 
PMA NumberP100034
Supplement NumberS014
Date Received08/21/2015
Decision Date02/09/2016
Product Code NZK 
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the following changes to the post-approval study for the device: modification to enrollment criteria.
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