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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/NEU (4B5) RABBITT 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 NumberS010
Date Received01/03/2011
Decision Date09/06/2011
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody assay migration to the benchmark ultra auto stainer, changes to pathway her-24 in 1 control slides, and minor software updates (vss 11. 7 to 11. 8).
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