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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 DualL ISH DNA Probe Cocktail
Generic NameChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
Regulation Number864.1890
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP190031
Supplement NumberS013
Date Received05/20/2025
Decision Date06/16/2025
Reclassified Date09/16/2026
Product Code NYQ 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the addition of an alternative supplier of a raw material
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