Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS001
Date Received06/11/2025
Decision Date07/11/2025
Product Code SER 
Advisory Committee Pathology
Clinical TrialsNCT03539536
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the clinical protocol titled Prevalence and Efficacy Assessment for VENTANA MET (SP44) RxDx Assay by the Different Cellular Compartments, for the post-approval study (PAS) protocol.
-
-