| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT |
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| Classification Name | stimulator, low electric field, tumor treatment |
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| Applicant | NOVOCURE, LTD. |
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| PMA Number | P100034 |
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| Date Received | 08/16/2010 |
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| Decision Date | 04/08/2011 |
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| Product Code | |
| Docket Number | 11M-0295 |
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| Notice Date | 05/06/2011 |
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| Advisory Committee |
Neurology |
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| Clinical Trials |
NCT00379470
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| Expedited Review Granted? | Yes |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the novottf-100a system. The device is indicated for treatment of adult patients (22 years of age or older) with histologically- confirmed glioblastoma multiforme, following histologically- or radiologically- confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for gbm after surgical and radiation options have been exhausted. |
| Approval Order |
Approval Order
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| Post-Approval Study | Show Report Schedule and Study Progress |
| Supplements: |
S001 S002 S003 |
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