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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 2INEU (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 NumberS008
Date Received10/21/2010
Decision Date11/17/2010
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in quality controls to ensure the safety in the use of the device by: 1) adding a test to ensure appropriate stain intensity of the primary antibody at the bulk manufacturing stages; and 2) adding a quality control testing steps at the raw material production and bulk manufacturing stages.
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