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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
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 e. innovation park dr.
tucson, AZ 85755
PMA NumberP100027
Supplement NumberS027
Date Received07/17/2017
Decision Date08/04/2017
Product Code NYQ 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Current suppliers new manufacturing site for a device component.
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