Cologuard®
FDA premarket approval P130017/S063 · decided 2025-07-18
Approval details
- PMA number
- P130017
- Supplement
- S063
- 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
- 2025-04-25
- Decision date
- 2025-07-18
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Approval of a labeling change affecting two PMAs Cologuard (P130017) and Cologuard Plus (P230043), to introduce a new "Dual Labeled Cologuard Collection Kit" that can be used with both Cologuard (P130017) and Cologuard Plus (P230043).
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