ColoSense®
FDA premarket approval P230001/S004 · decided 2024-09-06
Approval details
- PMA number
- P230001
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ColoSense®
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Applicant
- Geneoscopy, Inc.
- Date received
- 2024-08-09
- Decision date
- 2024-09-06
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- SBB
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- St. Louis, MO
- Statement
- approval of the protocol for the post-approval study (PAS).
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