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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.
 
DeviceHER2 Dual ISH DNA Probe Cocktail
Generic NameChromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP190031
Supplement NumberS015
Date Received08/15/2025
Decision Date05/15/2026
Product Code NYQ 
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 HER2 Dual ISH DNA Probe Cocktail as a companion diagnostic indication for the determination of HER2 gene amplification status in patients with breast cancer who may benefit from treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki).
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