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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesystem, colorectal neoplasia, dna methylation and hemoglobin detection
Generic Namesystem, colorectal neoplasia, dna methylation and hemoglobin detection
Exact Sciences Corporation
441 charmany drive
madison, WI 53719
PMA NumberP130017
Date Received06/07/2013
Decision Date08/11/2014
Product Code
PHP[ Registered Establishments with PHP ]
Docket Number 14M-1193
Notice Date 08/13/2014
Advisory Committee Pathology
Clinical Trials NCT01260168
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cologuard. Cologuard is intended for the qualitative detection of colorectal neoplasia associated dna markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (crc) or advanced adenoma (aa) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for crc. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012