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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 NumberS042
Date Received05/27/2020
Decision Date08/26/2020
Product Code PHP 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the clinical protocol titled A Real-World Study of Patients Under the Age of 50 Screened for Colorectal Cancer (CRC) Using Cologuard® in the U.S. ‘Tidal’, for the post-approval study (PAS) protocol.
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