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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 NameNOVO TTF-100A SYSTEM
Classification Namestimulator, low electric field, tumor treatment
ApplicantNOVOCURE, LTD.
PMA NumberP100034
Supplement NumberS008
Date Received01/27/2014
Decision Date07/24/2014
Product Code
NZK[ Registered Establishments with NZK ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to replace the current tyvek pouch packaging material for the 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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