PMA supplement
P130001 S007: Epi proColon
FDA PMA supplement · Real-Time Process · New Day Diagnostics, LLC
Key facts
| Original PMA | P130001 |
|---|---|
| Supplement number | S007 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Epi proColon |
| Generic name | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
| Applicant | New Day Diagnostics, LLC |
| Product code | PHP |
| Received date | Jun 21, 2021 |
| Decision date | Sep 20, 2021 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: