Cologuard®
FDA premarket approval P130017/S056 · decided 2023-10-05
Approval details
- PMA number
- P130017
- Supplement
- S056
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cologuard®
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2023-07-11
- Decision date
- 2023-10-05
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Approval for the modifications of the Cologuard test definition and system software to Test Definition v1.7 and System Software v2.2.
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