PMA
P250029: SimpleScreen™ CRC
FDA PMA · System, colorectal neoplasia, DNA methylation and hemoglobin detection · Freenome, LLC
Key facts
| PMA number | P250029 |
|---|---|
| Trade name | SimpleScreen™ CRC |
| Generic name | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
| Applicant | Freenome, LLC |
| Product code | PHP |
| Approval date | Jul 24, 2026 |
| Docket number | 26M-8165 |
| Notice date | Jul 24, 2026 |
At a glance
- 1–9 Supplements
- Aug 26, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: