Cologuard®
FDA premarket approval P130017/S065 · decided 2025-10-07
Approval details
- PMA number
- P130017
- Supplement
- S065
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cologuard®
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2025-09-10
- Decision date
- 2025-10-07
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- approval of manufacturing process changes
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