Cologuard®
FDA premarket approval P130017/S055 · decided 2023-03-16
Approval details
- PMA number
- P130017
- Supplement
- S055
- 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
- 2022-12-19
- Decision date
- 2023-03-16
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Approval for a Cologuard Quick Start Guide (QSG), to be a companion document to the Cologuard Patient Guide, as part of the Cologuard User Interface.
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