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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.
 
DeviceINFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
Generic NameChromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP100027
Supplement NumberS005
Date Received10/10/2012
Decision Date03/26/2013
Product Code NYQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR HARDWARE MODIFICATION AND SOFTWARE UPGRADES TO THE BENCHMARK, ULTRA INSTRUMENT. THE PURPOSE OFTHESE DESIGN CHANGES WAS TO IMPLEMENT ULTIMATE REAGENT ACCESS (URA) FEATURE ON THE BENCHMARK ULTRA INSTRUMENT.
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