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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.
 
DeviceINFORM HER2 DUAL ISH DNA PROBE COCKTAIL
Classification Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
Generic Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 e. innovation park dr.
tucson, AZ 85755
PMA NumberP100027
Supplement NumberS017
Date Received02/06/2014
Decision Date05/06/2014
Product Code
NYQ[ Registered Establishments with 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 A NEW ADHESIVE FOR THE SLIDE HEATERS ON THE BENCHMARK XT AND ULTRA AUTOMATED SLIDE STAINERS.
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