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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 Dr.
Tucson, AZ 85755
PMA NumberP210001
Supplement NumberS016
Date Received12/12/2025
Decision Date10/08/2026
Product Code QNH 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to add a new anti-PMS2 clone, VENTANA anti-PMS2 (SP487) Rabbit Monoclonal Primary Antibody, to the VENTANA MMR RxDx Panel for use on the BenchMark ULTRA and BenchMark ULTRA PLUS platforms
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