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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 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 TrialsNCT02715284
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 
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