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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
ApplicantExact Sciences Corporation
441 Charmany Dr.
Medison, WI 53719
PMA NumberP130017
Supplement NumberS060
Date Received08/19/2024
Decision Date11/12/2024
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Supplement P130017_S060 has been approved.
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