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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 NumberS070
Date Received05/22/2026
Decision Date06/09/2026
Product Code PHP 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
reagent scale-up and improvements to in-process QC method
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