| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | Cologuard® |
|---|
| Generic Name | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
|---|
| Applicant | Exact Sciences Corporation
441 Charmany Dr.
Medison, WI 53719 |
|---|
| PMA Number | P130017 |
|---|
| Supplement Number | S066 |
|---|
| Date Received | 09/11/2025 |
|---|
| Decision Date | 11/24/2025 |
|---|
| Product Code |
PHP |
| Advisory Committee |
Pathology |
|---|
| Supplement Type | Real-Time Process |
|---|
| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
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. |
|
|
