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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 SYSTEM
Generic Namestimulator, low electric field, tumor treatment
Applicant
Novocure GmbH
park 6
ch-6039 root d4 
PMA NumberP100034
Supplement NumberS003
Date Received01/29/2013
Decision Date04/17/2013
Product Code NZK 
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR SOFTWARE MODIFICATION TO ADD AN ALARM TO THE IDLE LOOP (THE NON-TREATMENT LOOP) TO INDICATE THAT THE DEVICE IS STILL POWERED ON EVEN WHEN TREATMENT IS NOT ACTIVE.
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