Cologuard® test
FDA premarket approval P130017/S064 · decided 2025-07-24
Approval details
- PMA number
- P130017
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cologuard® test
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2025-06-26
- Decision date
- 2025-07-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- approval of an alternative supplier of a raw material
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