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 | Optune System |
Generic Name | Stimulator, low electric field, tumor treatment |
Applicant | Novocure GmbH Park 6 CH-6039 Root D4 |
PMA Number | P100034 |
Supplement Number | S028 |
Date Received | 03/22/2021 |
Decision Date | 05/24/2021 |
Product Code |
NZK |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site, Synergy Health Däniken AG (Steris), located at Hogenweidstrasse 6, CH-4658, Daniken, Switzerland. This site is a sterilization facility used to sterilize the INE Transducer Arrays in the Optune System. |
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