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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, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM
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 NumberS010
Date Received10/26/2023
Decision Date11/08/2023
Product Code QNH 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
addition of an alternative supplier for dispenser component parts
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