PMA P230043

Device: Cologuard Plus™
Applicant: Exact Sciences Corporation
Product code: PHP
Decision date: 2026-05-27
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Approval order statement: Approval to implement updates to the in-process sample stability for both the homogenate sample and hemoglobin sample when stored at -15°C to -25°C for up to 60 days.

Current openFDA PMA Record#

Device: Cologuard Plus™
Applicant: Exact Sciences Corporation
PMA number: P230043
Supplement: S006
Product code: PHP
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Decision date: 2026-05-27
Decision code: APPR
Date received: 2026-03-05
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to implement updates to the in-process sample stability for both the homogenate sample and hemoglobin sample when stored at -15°C to -25°C for up to 60 days.