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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 NumberS002
Date Received05/23/2011
Decision Date09/27/2011
Product Code NKF 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A STRAINER TYPE BARRIER TO THE CURRENT DAB DISPENSER RETAINER DESIGN, COLORIZATION OF STOP BARREL, AND ASSEMBLY EQUIPMENT UPDATES TO ACCOMMODATE THE MODIFIED RETAINER.
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