• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NameNOVOTTF-100A SYSTEM
Classification Namestimulator, low electric field, tumor treatment
ApplicantNOVOCURE, INC
PMA NumberP100034
Supplement NumberS004
Date Received04/08/2013
Decision Date08/08/2013
Product Code
NZK[ Registered Establishments with NZK ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for transferring the responsibility of performing the novotal transducer array mapping from novocures staff to trained physicians responsible for prescribing the device.
-
-