PMA supplement
P150028 S007: CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP Stent (Model 42
FDA PMA supplement · Normal 180 Day Track · NuMED, Inc.
Key facts
| Original PMA | P150028 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP Stent (Model 42 |
| Generic name | Aortic stent |
| Applicant | NuMED, Inc. |
| Product code | PNF |
| Received date | Jul 21, 2025 |
| Decision date | Jul 6, 2026 |
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: