PMA P230001

Device: ColoSense®
Applicant: Geneoscopy, Inc.
Product code: SBB
Decision date: 2026-09-08
Generic name: System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
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.

Current openFDA PMA Record#

Device: ColoSense®
Applicant: Geneoscopy, Inc.
PMA number: P230001
Supplement: S014
Product code: SBB
Generic name: System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
Decision date: 2026-09-08
Decision code: APPR
Date received: 2026-06-22
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.