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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.
 
DeviceColoSense®
Generic NameSystem, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
ApplicantGeneoscopy, Inc.
2220 Welsch Industrial Ct.
St. Louis, MO 63146
PMA NumberP230001
Supplement NumberS009
Date Received07/16/2025
Decision Date09/15/2025
Product Code SBB 
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  
Submission is approved.
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