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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
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 NumberS007
Date Received11/19/2007
Decision Date12/12/2007
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Immunology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the raw material used to manufacture cell line multiblocks to eliminate background staining of the control slides.
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