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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 NumberS001
Date Received08/29/2011
Decision Date10/13/2011
Product Code
NYQ[ Registered Establishments with NYQ ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modification of the stability testing protocol to allow for extension of the shelf life of the device from 6 months to 18 months.
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