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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 (4B) 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 NumberS016
Date Received03/04/2013
Decision Date04/02/2013
Product Code MVC 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
ADD AN ALTERNATE QUALIFIED SUPPLIER FOR SUBASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS, CRITICAL COMPONENTSUSED IN THE MANUFACTURE OF THE SUBJECT REAGENTS.
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