Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | VENTANA MMR RxDx Panel |
Generic Name | immunohistochemistry test, dna mismatch repair (mmr) protein assay |
Regulation Number | 864.1860 |
Applicant | Ventana Medical Systems 1910 e innovation park drive tucson, AZ 85755 |
PMA Number | P200019 |
Date Received | 03/16/2020 |
Decision Date | 04/22/2021 |
Product Code |
QNH |
Docket Number | 21M-0416 |
Notice Date | 04/29/2021 |
Advisory Committee |
Pathology |
Clinical Trials | NCT02715284
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Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Ventana MMR RxDx Pavel as a CDx for identifying patients with endometrial cancer with dMMR status who may benefit from treatment with Jemperli. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S003 S004 S005 |
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