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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceVENTANA MMR RxDx Panel
Generic Nameimmunohistochemistry test, dna mismatch repair (mmr) protein assay
Regulation Number864.1860
Applicant
Ventana Medical Systems
1910 east 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 Trials NCT02715284
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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