Cologuard
FDA premarket approval P130017/S042 · decided 2020-08-26
Approval details
- PMA number
- P130017
- Supplement
- S042
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Cologuard
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2020-05-27
- Decision date
- 2020-08-26
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Approval of the clinical protocol titled A Real-World Study of Patients Under the Age of 50 Screened for Colorectal Cancer (CRC) Using Cologuard® in the U.S. Tidal, for the post-approval study (PAS) protocol.
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