|
Trade Name | Optune Lua |
Classification Name | electrical tumor treatment fields |
Generic Name | electrical tumor treatment fields |
Applicant |
Novocure, GmbH |
park 6 |
ch-6039 root d4 |
lucerne |
|
HDE Number | H180002 |
Supplement Number | S002 |
Date Received | 01/22/2021 |
Decision Date | 04/02/2021 |
Product Code | |
Advisory Committee |
Anesthesiology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modification of the device from the novottf-100l generation 1. 5 model to the novottf-200t generation 2 model. |