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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 PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)
Generic NameImmunohistochemistry antibody assay, c-kit
Regulation Number864.1860
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP020055
Supplement NumberS018
Date Received12/10/2015
Decision Date04/13/2016
Product Code NKF 
Advisory Committee Pathology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the following:1) Enlargement of a bulk formulation room at Ventana Medical Systems' Tucson, AZ facility; and 2) addition of two large volume tanks, along with supply plumbing, a clean in place (CIP) procedure, and new filler, as well as a new fill line.
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