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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-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP990081
Supplement NumberS029
Date Received02/14/2014
Decision Date08/06/2014
Product Code MVC 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDITION OF THE FACILITY AT ROCHE IN PENZBERG, GERMANY FOR MANUFACTURING THE RAW MATERIAL (ANTIBODY) FOR THE PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY EMPLOYING A DIFFERENT CELL CULTURE MEDIA.
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