PMA supplement
P130001 S009: ColoHealth
FDA PMA supplement · Normal 180 Day Track No User Fee · New Day Diagnostics, LLC
Key facts
| Original PMA | P130001 |
|---|---|
| Supplement number | S009 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | ColoHealth |
| Generic name | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
| Applicant | New Day Diagnostics, LLC |
| Product code | PHP |
| Received date | Oct 1, 2024 |
| Decision date | Mar 19, 2025 |
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: