PMA
P180011: Eluvia Drug-Eluting Vascular Stent System
FDA PMA · Stent, superficial femoral artery, drug-eluting · Boston Scientific Corp
Key facts
| PMA number | P180011 |
|---|---|
| Trade name | Eluvia Drug-Eluting Vascular Stent System |
| Generic name | Stent, superficial femoral artery, drug-eluting |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | NIU |
| Approval date | Sep 18, 2018 |
| Docket number | 18M-3548 |
| Notice date | Sep 20, 2018 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 10–99 Supplements
- Aug 21, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: