PMA P230043S007

Device: Cologuard Plus™
Applicant: Exact Sciences Corporation
PMA number: P230043
Supplement: S007
Product code: PHP
Decision date: 2026-06-02
Classification: Pathology
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Approval order statement: Approval to use a new Class I instrument, referred to as the Capture Aspiration Module (CAM), in the laboratory workflow of the Cologuard Plus test.

Current openFDA PMA Record#

Device: Cologuard Plus™
Applicant: Exact Sciences Corporation
PMA number: P230043
Supplement: S007
Product code: PHP
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Decision date: 2026-06-02
Decision code: APPR
Date received: 2026-03-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to use a new Class I instrument, referred to as the Capture Aspiration Module (CAM), in the laboratory workflow of the Cologuard Plus test.