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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 HER2 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 NumberS007
Date Received03/12/2013
Decision Date07/23/2013
Product Code NYQ 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS IN DESIGN TO PREVENT WASTE SYSTEM OVERFLOW OR OTHER LEAKS FROM CAUSING SHORTING CONDITIONS WITH THE BENCHMARK ULTRAS INTERNAL CIRCUITS.
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