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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 drive
tucson, AZ 85755
PMA NumberP190031
Supplement NumberS005
Date Received07/12/2022
Decision Date07/29/2022
Product Code NYQ 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of alternative suppliers for component parts.
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