Cologuard®
FDA premarket approval P130017/S066 · decided 2025-11-24
Approval details
- PMA number
- P130017
- Supplement
- S066
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Cologuard®
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2025-09-11
- Decision date
- 2025-11-24
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which qualified for review under the Real-Time Review Program. Your supplement requested to modify the in-process sample stability of the hemoglobin sample from 7 days to 14 days at 2 to 8°C, and additional minor labeling changes. Based upon the information submitted, the PMA supplement is approved. You may begin commerc
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