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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.
 
DeviceCologuard®
Generic NameSystem, colorectal neoplasia, DNA methylation and hemoglobin detection
ApplicantExact Sciences Corporation
441 Charmany Dr.
Medison, WI 53719
PMA NumberP130017
Supplement NumberS063
Date Received04/25/2025
Decision Date07/18/2025
Product Code PHP 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of a labeling change affecting two PMAs Cologuard (P130017) and Cologuard Plus (P230043), to introduce a new "Dual Labeled Cologuard Collection Kit" that can be used with both Cologuard (P130017) and Cologuard Plus (P230043).
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