PMA P130017S066

Device: Cologuard®
Applicant: Exact Sciences Corporation
PMA number: P130017
Supplement: S066
Product code: PHP
Decision date: 2025-11-24
Classification: Pathology
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which qualified for review under the Real-Time Review Program. Your supplement requested to modify the in-process sample stability of the hemoglobin sample from 7 days to 14 days at 2 to 8°C, and additional minor labeling changes. Based upon the information submitted, the PMA supplement is approved. You may begin commercial distribution of the device as modified by your PMA supplement in accordance with the conditions described below. Although this letter refers to your product as a device, please be aware that some approved products may instead be combination products.

Current openFDA PMA Record#

Device: Cologuard®
Applicant: Exact Sciences Corporation
PMA number: P130017
Supplement: S066
Product code: PHP
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Decision date: 2025-11-24
Decision code: APPR
Date received: 2025-09-11
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which qualified for review under the Real-Time Review Program. Your supplement requested to modify the in-process sample stability of the hemoglobin sample from 7 days to 14 days at 2 to 8°C, and additional minor labeling changes. Based upon the information submitted, the PMA supplement is approved. You may begin commercial distribution of the device as modified by your PMA supplement in accordance with the conditions described below. Although this letter refers to your product as a device, please be aware that some approved products may instead be combination products.