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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 LTD'S NOVOTTF-100A TREATMENT KIT
Generic Namestimulator, low electric field, tumor treatment
ApplicantNovocure GmbH
park 6
ch-6039 root d4 
PMA NumberP100034
Supplement NumberS016
Date Received02/17/2016
Decision Date03/18/2016
Product Code NZK 
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Additional servicing and repair location for the Optune System.
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