PMA
P940019: WALLSTENT(R) ILIAC ENDOPROSTHESIS
FDA PMA · STENT, ILIAC · Boston Scientific Scimed, Inc.
Key facts
| PMA number | P940019 |
|---|---|
| Trade name | WALLSTENT(R) ILIAC ENDOPROSTHESIS |
| Generic name | STENT, ILIAC |
| Applicant | Boston Scientific Scimed, Inc. |
| Owner/operator | Boston Scientific Corporation |
| Product code | NIO |
| Approval date | May 28, 1996 |
| Docket number | 97M-0054 |
| Notice date | Feb 21, 1997 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 10–99 Supplements
- May 6, 2026 Latest supplement decision
- No Withdrawn
- No 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: