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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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
Supplement NumberS008
Date Received11/29/2022
Decision Date05/26/2023
Product Code QNH 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of PAS that was submitted to comply with the condition of approval #1 which required providing data to support the analytical sensitivity of the VENTANA MMR RxDx Panel for the solid tumor indication.
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