|
Device | NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT |
Generic Name | Stimulator, low electric field, tumor treatment |
Applicant | Novocure GmbH Park 6 CH-6039 Root D4 |
PMA Number | P100034 |
Supplement Number | S016 |
Date Received | 02/17/2016 |
Decision Date | 03/18/2016 |
Product Code |
NZK |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Additional servicing and repair location for the Optune System. |