PMA
P130001: Epi proColon
FDA PMA · System, colorectal neoplasia, DNA methylation and hemoglobin detection · New Day Diagnostics, LLC
Key facts
| PMA number | P130001 |
|---|---|
| Trade name | Epi proColon |
| Generic name | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
| Applicant | New Day Diagnostics, LLC |
| Owner/operator | New Day Diagnostics |
| Product code | PHP |
| Approval date | Apr 12, 2016 |
| Docket number | 16M-1168 |
| Notice date | May 20, 2016 |
| Establishment registration | 3032518803 |
| FEI number | 3032518803 |
At a glance
- 1–9 Supplements
- Mar 19, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: