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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.
 
DeviceCINtec PLUS Cytology
Generic NameImmunocytochemistry assay, p16/Ki-67
Regulation Number864.1860
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP190024
Supplement NumberS001
Date Received04/28/2020
Decision Date08/14/2020
Product Code QKF 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for expanding the indications for use to add the cobas® 6800/8800 Systems (cobas® HPV) test to identify HPV positive patients.
LabelingLabeling
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