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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.
 
DeviceMAGE-A4 IHC 1F9 pharmDx
Generic NameImmunohistochemistry Assay, Antibody, Melanoma-associated antigen A4
Regulation Number864.1860
ApplicantAgilent Technologies, Inc.
6392 Via Real
Carpinteria, CA 93013
PMA NumberP230016
Supplement NumberS001
Date Received01/31/2025
Decision Date02/28/2025
Product Code SBL 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for additional quality control tests to raw materials and intermediates that to enhance safety of the finished devices without impacting effectiveness.
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