PMA P230043
- Device
- Cologuard Plus™
- Applicant
- Exact Sciences Corporation
- Product code
- PHP
- Decision date
- 2026-06-09
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- reagent scale-up and improvements to in-process QC method
Current openFDA PMA Record#
- Device
- Cologuard Plus™
- Applicant
- Exact Sciences Corporation
- PMA number
- P230043
- Supplement
- S009
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2026-06-09
- Decision code
- OK30
- Date received
- 2026-05-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reagent scale-up and improvements to in-process QC method