Cologuard
FDA premarket approval P130017/S037 · decided 2020-07-14
Approval details
- PMA number
- P130017
- Supplement
- S037
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cologuard
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2020-01-30
- Decision date
- 2020-07-14
- Days to decision
- 166 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Approval for a manufacturing site located at Exact Sciences Corporation, 650 Forward Drive, Madison, Wisconsin.
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