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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.
 
DeviceOPTUNE
Generic NameStimulator, low electric field, tumor treatment
ApplicantNovocure GmbH
Park 6
CH-6039 Root D4 
PMA NumberP100034
Supplement NumberS010
Date Received05/30/2014
Decision Date09/28/2014
Product Code NZK 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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