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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
Applicant
Ventana Medical Systems, Inc.
1910 e. innovation park drive
tucson, AZ 85755
PMA NumberP190031
Supplement NumberS001
Date Received08/26/2020
Decision Date11/13/2020
Product Code NYQ 
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the replacement of dispenser molds used in the injection molding process for six (6) dispenser parts.
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