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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.
 
DeviceVENTANA HER2 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 NumberS016
Date Received03/25/2026
Decision Date08/25/2026
Product Code NYQ 
Docket Number 26M-9736
Notice Date 08/25/2026
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 of VENTANA HER2 Dual ISH DNA Probe Cocktail to add the indication for use as a companion diagnostic (CDx) for identifying patients with gastroesophageal adenocarcinoma (GEA; gastric, gastroesophageal junction and esophageal adenocarcinoma) who many benefit from treatment with ZIIHERA (zanidatamab).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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