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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 NumberS013
Date Received08/26/2020
Decision Date11/13/2020
Product Code PKW 
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the replacement of dispenser molds used in the injection molding process for six (6) dispenser parts.
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