PMA P130017S068

Device: Cologuard®
Applicant: Exact Sciences Corporation
PMA number: P130017
Supplement: S068
Product code: PHP
Decision date: 2026-05-27
Classification: Pathology
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®
Applicant: Exact Sciences Corporation
PMA number: P130017
Supplement: S068
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.