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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.
 
DeviceNOVOTTF-100A TREATMENT KIT
Generic NameStimulator, low electric field, tumor treatment
ApplicantNovocure GmbH
Park 6
CH-6039 Root D4 
PMA NumberP100034
Supplement NumberS009
Date Received03/20/2014
Decision Date07/25/2014
Product Code NZK 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO REPLACE THE CURRENT TYVEK POUCH PACKAGING MATERIAL FORTHE INE TRANSDUCER ARRAYS WITH AN ALUMINUM FOIL MOISTURE BARRIER AND TO EXTEND THE SHELF LIFE FOR THESE TRANSDUCER ARRAYS FROM 6 TO 9 MONTHS.
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