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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 (Endometrial Cancer with dMMR status)
Generic NameImmunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Regulation Number864.1860
ApplicantVentana Medical Systems
1910 E Innovation Park Drive
Tucson, AZ 85755
PMA NumberP200019
Supplement NumberS004
Date Received02/16/2022
Decision Date07/21/2022
Product Code QNH 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.
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