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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 drive
tucson, AZ 85755
PMA NumberP210001
Supplement NumberS002
Date Received12/20/2021
Decision Date06/16/2022
Product Code QNH 
Advisory Committee Pathology
Clinical TrialsNCT03517449
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the VENTANA MMR RxDx Panel as a companion diagnostic for identifying MMR proficient (pMMR) patients with endometrial cancer for treatment with KEYTRUDA in combination with LENVIMA.
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