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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 Drive
Madison, WI 53719
PMA NumberP130017
Supplement NumberS002
Date Received05/20/2015
Decision Date08/18/2015
Product Code PHP 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO EXTEND THE SHELF LIFE OF THE COLOGUARD ASSAY REAGENTS(COLOGUARD MOLECULAR ASSAY REAGENTS, COLOGUARD MOLECULAR CONTROLS, COLOGUARD HEMOGLOBIN ASSAY REAGENTS, AND COLOGUARD HEMOGLOBIN CONTROLS), ON THE BASIS OF ADDITIONAL REAL-TIME STABILITY TESTING, FROM A SHELF-LIFE OF SIX (6) MONTHS TO A SHELF-LIFE OF NINE (9) MONTHS.
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