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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 NumberS004
Date Received08/09/2024
Decision Date09/06/2024
Product Code SBB 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the protocol for the post-approval study (PAS).
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