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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.
 
DevicePATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
Classification Namesystem, test, her-2/neu, ihc
Generic Namesystem, test, her-2/neu, ihc
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 e. innovation park dr.
tucson, AZ 85755
PMA NumberP990081
Supplement NumberS020
Date Received05/07/2013
Decision Date10/25/2013
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR ADDITION OF A NEW SUPPLIER OF BIOCONJUGATES FOR THE ULTRAVIEW UNIVERSAL DAB DETECTION KIT. THE DETECTION KIT IS PART OF THE PATHWAY ANTI-HER 2/NEU RABBIT MONOCLONAL PRIMARY ANTIBODY (4B5).
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