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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 Dr.
Tucson, AZ 85755
PMA NumberP200019
Supplement NumberS003
Date Received01/28/2022
Decision Date06/10/2022
Product Code QNH 
Advisory Committee Pathology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of two new contract manufacturers as approved suppliers for component parts.
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