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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 NumberS013
Date Received07/17/2024
Decision Date12/18/2024
Product Code QNH 
Advisory Committee Pathology
Clinical TrialsNCT04269200
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval to include a companion diagnostic indication to identify adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient, who are eligible for treatment with IMFINZI® (durvalumab) in combination with carboplatin and paclitaxel, followed by IMFINZI® (durvalumab) as a single agent.
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