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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCOLOGUARD
Classification Namesystem, colorectal neoplasia, dna methylation and hemoglobin detection
ApplicantEXACT SCIENCES CORPORATION
PMA NumberP130017
Supplement NumberS001
Date Received09/10/2014
Decision Date02/02/2015
Product Code
PHP[ Registered Establishments with PHP ]
Advisory Committee Pathology
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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