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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) RABBITT MONOCLONAL PRIMARY ANTOBODY
Generic NameImmunohistochemistry antibody assay, c-kit
Regulation Number864.1860
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP020055
Supplement NumberS010
Date Received10/11/2013
Decision Date06/13/2014
Product Code NKF 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDITION OF A NEW SUPPLIER FOR PRODUCTION OF THE BULK RAW MATERIAL AND FOR A DESIGN CHANGE WHERE THE UNPURIFIED CELL CULTURE MEDIUM DILUTING THE BULK RAW MATERIAL WILL SWITCH FROM AN RPMI-BASED SOLUTION TO AN E-RDF 5-BASED SOLUTION.
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