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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 NamePATWAY HER-2/NEU (4B5) 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 NumberS012
Date Received07/25/2012
Decision Date08/21/2012
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Immunology
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an extension of shelf life of the iview dab detection kit and the ultraview dab detection kit for the pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody.
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