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. |
|
Device | NOVOTTF-100A SYSTEM |
Generic Name | Stimulator, low electric field, tumor treatment |
Applicant | Novocure GmbH Park 6 CH-6039 Root D4 |
PMA Number | P100034 |
Supplement Number | S003 |
Date Received | 01/29/2013 |
Decision Date | 04/17/2013 |
Product Code |
NZK |
Advisory Committee |
Neurology |
Supplement Type | Real-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. |
|
|