Cologuard
FDA premarket approval P130017/S024 · decided 2018-10-29
Approval details
- PMA number
- P130017
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cologuard
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2018-10-17
- Decision date
- 2018-10-29
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Implementation of manufacturing changes to a wash component of the Cologuard sDNA based colorectal cancer screening test.
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