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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.
 
DeviceVENTANA ALK (D5F3) CDx Assay
Generic NameImmunohistochemistry assay, antibody, anaplastic lymphoma kinase
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 EAST INNOVATION PARK DR.
TUCSON, AZ 85755
PMA NumberP140025
Supplement NumberS012
Date Received01/13/2020
Decision Date03/31/2020
Product Code PKW 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for minor software changes.
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