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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceHER2 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
Date Received11/29/2019
Decision Date07/28/2020
Product Code NYQ 
Docket Number 20M-1724
Notice Date 07/31/2020
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the VENTANA HER2 Dual ISH DNA Probe Cocktail assay.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements:  S001 
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