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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCOLOGUARD
Generic Namesystem, colorectal neoplasia, dna methylation and hemoglobin detection
Applicant
Exact Sciences Corporation
441 charmany drive
madison, WI 53719
PMA NumberP130017
Date Received06/07/2013
Decision Date08/11/2014
Product Code PHP 
Docket Number 14M-1193
Notice Date 08/13/2014
Advisory Committee Pathology
Clinical Trials NCT01260168
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
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:  S016 S013 S018 S012 S009 S008 S019 S011 
S007 S006 S005 S010 S017 S014 S015 S004 S001 
S003 S002 S047 S048 S045 S046 S025 S036 S035 
S040 S039 S028 S030 S038 S033 S043 S034 S041 
S044 S031 S032 S026 S024 S022 S021 S023 S020 
S037 S042 S029 S027 
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