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® device |
Generic Name | Stimulator, low electric field, tumor treatment |
Applicant | Novocure GmbH Park 6 CH-6039 Root D4 |
PMA Number | P100034 |
Supplement Number | S029 |
Date Received | 02/14/2022 |
Decision Date | 05/10/2022 |
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 specifications of the ceramic discs used in the INE Transducer Arrays to make them lead-free, and the addition of a new supplier for these lead-free ceramic discs, Vishay Electronics GmbH, located at Dr.-Felix-Zandman-Platz 1, Selb 95100, Germany. |
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