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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 HER2 DUAL ISH DNA PROBE COCKTAIL
Classification Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
ApplicantVENTANA MEDICAL SYSTEMS, INC.
PMA NumberP100027
Supplement NumberS009
Date Received05/10/2013
Decision Date07/25/2013
Product Code
NYQ
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor modifications to the design of the dispenser in which the pma reagents in the devices are stored and or used, including a change in the materials the various dispenser parts are made from.
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