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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 NumberS047
Date Received05/27/2022
Decision Date09/30/2022
Product Code MVC 
Docket Number 22M-2439
Notice Date 10/07/2022
Advisory Committee Pathology
Clinical TrialsNCT03734029
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 for expanding the indications to include testing for breast cancer patients who are eligible for treatment with ENHERTU®.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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