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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameOPTUNE
Classification Namestimulator, low electric field, tumor treatment
ApplicantNOVOCURE, LTD.
PMA NumberP100034
Supplement NumberS010
Date Received05/30/2014
Decision Date09/28/2014
Product Code
NZK[ Registered Establishments with NZK ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a trade name change from the novottf-100a system to optune¿. You have also requested that the components of the novottf-100a system (a plugin power supply; charger for portable batteries; device & battery carrying bag; portable battery; and, connection cable & box), along with the transducer array and electric field generator (the device), be named the optune¿ treatment kit.
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