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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 ISI-I DNA Probe Cocktail
Generic NameChromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Drive
Tucson, AZ 85755
PMA NumberP190031
Supplement NumberS002
Date Received02/22/2021
Decision Date05/20/2021
Product Code NYQ 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the dispenser resin replacement used in the injection molding process for six (6) dispenser parts.