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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.
 
DevicePATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP990081
Supplement NumberS058
Date Received08/15/2025
Decision Date05/15/2026
Product Code MVC 
Advisory Committee Pathology
Clinical TrialsNCT05113251
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to include the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY anti-HER2 (4B5) antibody) as a companion diagnostic indication for the detection of HER2 antigen in patients with breast cancer who may benefit from treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki).
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