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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINFORM HER-2/NEU
Classification Namesystem, test, her-2/neu, nucleic acid or serum
ApplicantVENTANA MEDICAL SYSTEMS, INC.
PMA NumberP940004
Supplement NumberS001
Date Received07/10/2000
Decision Date08/01/2000
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Raw material substitution of replacing nonidet p-40, raw material with igepal ca-630, and changes for the use of dry powders or solutions that are purchased rather than manufactured while keeping the final formulation and specifications the same.
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