|
Device | NOVOCURE 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 | S001 |
Date Received | 05/04/2011 |
Decision Date | 01/03/2012 |
Product Code |
NZK |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |