Cologuard
FDA premarket approval P130017/S048 · decided 2021-03-25
Approval details
- PMA number
- P130017
- Supplement
- S048
- 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
- 2021-03-01
- Decision date
- 2021-03-25
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Transfer of scaled-up manufacturing processes and testing methods to a previously approved manufacturing facility.
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