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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 MET (SP44) RxDx Assay
Generic NameImmunohistochemistry Assay, Antibody, MET
Regulation Number864.1860
ApplicantVentana Medical Systems, Inc. (Roche Tissue Diagnostics)
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP240037
Supplement NumberS003
Date Received08/12/2026
Decision Date10/23/2026
Product Code SER 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to update the labeling for the VENTANA MET (SP44) RxDx Assay to include results of supplemental data provided in the Post-Approval Study (PAS) Report P240037/R004 for utilization of SurePath for preparation of cytology specimens.
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