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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 Inc (Roche Tissue Diagnostics)
1910 e. innovation park drive
tucson, AZ 85755
PMA NumberP210001
Date Received01/22/2021
Decision Date08/17/2021
Product Code QNH 
Docket Number 21M-0915
Notice Date 08/25/2021
Advisory Committee Pathology
Clinical Trials NCT02715284
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Ventana MMR RxDx Panel as a CDx for identifying patients with solid tumors with dMMR status who may benefit from treatment with JEMPERLI.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements:  
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