PMA supplement
P240010 S001: MI Cancer Seek
FDA PMA supplement · Real-Time Process · Caris Life Sciences
Key facts
| Original PMA | P240010 |
|---|---|
| Supplement number | S001 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MI Cancer Seek |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Caris Life Sciences |
| Product code | PQP |
| Received date | Nov 8, 2024 |
| Decision date | Feb 6, 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: