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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
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