PMA
P150028: CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
FDA PMA · Aortic stent · NuMED, Inc.
Key facts
| PMA number | P150028 |
|---|---|
| Trade name | CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) |
| Generic name | Aortic stent |
| Applicant | NuMED, Inc. |
| Owner/operator | NUMED, INC. |
| Product code | PNF |
| Approval date | Mar 25, 2016 |
| Docket number | 16M-1122 |
| Notice date | Apr 12, 2016 |
| Establishment registration | 1318694 |
| FEI number | 1318694 |
At a glance
- 1–9 Supplements
- Jul 6, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: