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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.
 
DevicePATHWAY Anti-c-KIT (9.7) Primary Antibody
Generic NameImmunohistochemistry antibody assay, c-kit
Regulation Number864.1860
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP020055
Supplement NumberS023
Date Received08/26/2020
Decision Date11/13/2020
Product Code NKF 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for replacement of dispenser molds used in the injection molding process for six (6) dispenser parts.
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