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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 NumberS014
Date Received06/22/2026
Decision Date09/08/2026
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  
ColoSense Sample preservative shelf-life extension from the original PMA approval of 12 months to 18 months in this current supplement S014.
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