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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePATHWAY ANTI-HER 2INEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
Classification Namesystem, test, her-2/neu, ihc
Generic Namesystem, test, her-2/neu, ihc
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 e. innovation park dr.
tucson, AZ 85755
PMA NumberP990081
Supplement NumberS008
Date Received10/21/2010
Decision Date11/17/2010
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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