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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 NumberS005
Date Received12/28/2016
Decision Date05/26/2017
Product Code PKW 
Advisory Committee Pathology
Clinical TrialsNCT01828099
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for extending the label claim of the VENTANA ALK (D5F3) CDx Assay to include an indication for Zykadia (ceritinib)
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