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 | 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 | S002 |
Date Received | 09/28/2012 |
Decision Date | 12/03/2012 |
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 MODIFICATION TO THE FIELD GENERATOR COMPONENT OF THENOVOTTF-L00A SYSTEM TO REPLACE PIN: DAC7614E WITH PIN: 2IC-103572, AND CORRESPONDING CHANGES TO THE ASSOCIATED RESISTORS AND CAPACITORS TO LIMIT THE PART VOLTAGE RANGE AND ELIMINATE AN OBSERVED CURRENT SPIKE. CORRESPONDING SOFTWARE CHANGES WERE ALSO MADE TO REFLECT THESEMODIFICATIONS. |
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