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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-HER2/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 NumberS015
Date Received01/14/2013
Decision Date03/20/2013
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change from fluorinated bottles to non-fluorinated bottles for storage of the general purpose reagents used in the staining with the pathway and anti-her-2/neu (4b5) rabbit monoclonal primary antibody.
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