PMA
P230043: Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™
FDA PMA · System, colorectal neoplasia, DNA methylation and hemoglobin detection · Exact Sciences Corporation
Key facts
| PMA number | P230043 |
|---|---|
| Trade name | Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™ |
| Generic name | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
| Applicant | Exact Sciences Corporation |
| Owner/operator | Exact Sciences Corporation |
| Product code | PHP |
| Approval date | Oct 3, 2024 |
| Docket number | 24M-4797 |
| Establishment registration | 3015728010 |
| FEI number | 3015728010 |
At a glance
- 10–99 Supplements
- Aug 3, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: