PMA P130017S063

Device: Cologuard®
Applicant: Exact Sciences Corporation
PMA number: P130017
Supplement: S063
Product code: PHP
Decision date: 2025-07-18
Classification: Pathology
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Approval order statement: Approval of a labeling change affecting two PMAs Cologuard (P130017) and Cologuard Plus (P230043), to introduce a new "Dual Labeled Cologuard Collection Kit" that can be used with both Cologuard (P130017) and Cologuard Plus (P230043).

Current openFDA PMA Record#

Device: Cologuard®
Applicant: Exact Sciences Corporation
PMA number: P130017
Supplement: S063
Product code: PHP
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Decision date: 2025-07-18
Decision code: APPR
Date received: 2025-04-25
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval of a labeling change affecting two PMAs Cologuard (P130017) and Cologuard Plus (P230043), to introduce a new "Dual Labeled Cologuard Collection Kit" that can be used with both Cologuard (P130017) and Cologuard Plus (P230043).