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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.
 
DevicePATWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP990081
Supplement NumberS012
Date Received07/25/2012
Decision Date08/21/2012
Product Code MVC 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN EXTENSION OF SHELF LIFE OF THE IVIEW DAB DETECTIONKIT AND THE ULTRAVIEW DAB DETECTION KIT FOR THE PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY.
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