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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/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY
Generic Namesystem, test, her-2/neu, ihc
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 e. innovation park dr.
tucson, AZ 85755
PMA NumberP990081
Supplement NumberS030
Date Received06/16/2014
Decision Date02/19/2015
Product Code 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 No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF SANMINA BUILT NOZZLE PLATE ASSEMBLY IN THE MANUFACTURE OF BENCHMARK XT INSTRUMENT USED IN THE TESTS.
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