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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceVENTANA MMR RxDx Panel
Generic Nameimmunohistochemistry test, dna mismatch repair (mmr) protein assay
Regulation Number864.1860
ApplicantVentana Medical Systems
1910 e innovation park drive
tucson, AZ 85755
PMA NumberP200019
Date Received03/16/2020
Decision Date04/22/2021
Product Code QNH 
Docket Number 21M-0416
Notice Date 04/29/2021
Advisory Committee Pathology
Clinical TrialsNCT02715284
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S003 S004 S005 S006 
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