PMA
P930031: WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA PMA · SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS · Boston Scientific Corp
Key facts
| PMA number | P930031 |
|---|---|
| Trade name | WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM |
| Generic name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | MIR |
| Approval date | Sep 29, 1995 |
| Docket number | 96M-0238 |
| Notice date | Jul 17, 1996 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 10–99 Supplements
- Jun 27, 2024 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- No Withdrawn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: