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. |
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Device | NOVOTFF-100A SYSTEM |
Generic Name | Stimulator, low electric field, tumor treatment |
Applicant | Novocure GmbH Park 6 CH-6039 Root D4 |
PMA Number | P100034 |
Supplement Number | S007 |
Date Received | 05/12/2014 |
Decision Date | 11/12/2014 |
Product Code |
NZK |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE NOVOTTF-100A INSULATED ELECTRODE (INE) TRANSDUCER ARRAY MANUFACTURING PROCESS TO IMPROVE ITS EFFICIENCY BY AUTOMATING CERTAIN MANUAL PROCESSING STEPS. |
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