PMA
P180013: VICI VENOUS STENT System
FDA PMA · Stent, iliac vein · Boston Scientific Corporation
Key facts
| PMA number | P180013 |
|---|---|
| Trade name | VICI VENOUS STENT System |
| Generic name | Stent, iliac vein |
| Applicant | Boston Scientific Corporation |
| Owner/operator | Boston Scientific Corporation |
| Product code | QAN |
| Approval date | May 2, 2019 |
| Docket number | 19M-2193 |
| Notice date | May 10, 2019 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 1–9 Supplements
- Jun 29, 2021 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- No Withdrawn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: