PMA supplement
P130017 S043: Cologuard
FDA PMA supplement · 30-Day Notice · Exact Sciences Corporation
Key facts
| Original PMA | P130017 |
|---|---|
| Supplement number | S043 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Cologuard |
| Generic name | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
| Applicant | Exact Sciences Corporation |
| Product code | PHP |
| Received date | Sep 9, 2020 |
| Decision date | Oct 7, 2020 |
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: