COLOGUARD
FDA premarket approval P130017/S057 · decided 2024-07-20
Approval details
- PMA number
- P130017
- Supplement
- S057
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- COLOGUARD
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2024-01-26
- Decision date
- 2024-07-20
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Approval for updating Cologuard labeling to include the completed Post-Approval study information.
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