PMA P130017S061
- Device
- Cologuard®
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S061
- Product code
- PHP
- Decision date
- 2025-03-20
- Classification
- Pathology
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- Supplement P130017_S061 has been approved.
Current openFDA PMA Record#
- Device
- Cologuard®
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S061
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2025-03-20
- Decision code
- APPR
- Date received
- 2024-12-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Supplement P130017_S061 has been approved.