Cologuard Stool DNA-Based Colorectal Cancer Screening Test
FDA premarket approval P130017/S029 · decided 2019-09-20
Approval details
- PMA number
- P130017
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Cologuard Stool DNA-Based Colorectal Cancer Screening Test
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2019-04-12
- Decision date
- 2019-09-20
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Approval to expand the indicated age range for Cologuard Stool DNA-Based Colorectal Cancer Screening Test from 50 years or older to 45 years or older.
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