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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
ApplicantVentana Medical Systems, Inc. (Roche Tissue Diagnostics)
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP210001
Supplement NumberS012
Date Received12/11/2023
Decision Date12/20/2024
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 for assay migration of VENTANA MMR RxDx Panel from the BenchMark ULTRA platform to BenchMark ULTRA PLUS platform.
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