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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 Stool DNA-Based Colorectal Cancer Screening Test
Generic NameSystem, colorectal neoplasia, DNA methylation and hemoglobin detection
ApplicantExact Sciences Corporation
441 Charmany Dr.
Medison, WI 53719
PMA NumberP130017
Supplement NumberS029
Date Received04/12/2019
Decision Date09/20/2019
Product Code PHP 
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 to expand the indicated age range for Cologuard Stool DNA-Based Colorectal Cancer Screening Test from 50 years or older to 45 years or older.
Post-Approval StudyShow Report Schedule and Study Progress
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