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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 NumberS060
Date Received03/25/2026
Decision Date08/25/2026
Product Code MVC 
Docket Number FDA-9903
Notice Date 08/26/2026
Advisory Committee Pathology
Clinical TrialsNCT05152147
Supplement TypePanel 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 for the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody as a companion diagnostic (CDx) for identifying patients with gastroesophageal adenocarcinoma (gastric, gastroesophageal junction, and esophageal adenocarcinoma) who may be eligible for treatment with ZIIHERA (zanidatamab).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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