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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePATHWAY ANTI-HER-2 (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY
Classification Namesystem, test, her-2/neu, ihc
Generic Namemouse monoclonal antibody for aid in the detection of c-eerbb-2 antigen in histological tissue section
ApplicantVENTANA MEDICAL SYSTEMS, INC.
PMA NumberP990081
Supplement NumberS016
Date Received03/05/2013
Decision Date04/02/2013
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add an alternate qualified supplier for subassemblies used in the production of the benchmark ultra and benchmark xt instruments, critical components used in the manufacture of the subject reagents.
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