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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
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 east innovation park dr.
tucson, AZ 85755
PMA NumberP140025
Supplement NumberS007
Date Received07/17/2017
Decision Date08/04/2017
Product Code PKW 
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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