PMA
P030045: INTRASTENT DOUBLESTRUT STENT
FDA PMA · STENT, ILIAC · Medtronic Vascular, Inc.
Key facts
| PMA number | P030045 |
|---|---|
| Trade name | INTRASTENT DOUBLESTRUT STENT |
| Generic name | STENT, ILIAC |
| Applicant | Medtronic Vascular, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NIO |
| Approval date | Jun 8, 2004 |
| Docket number | 04M-0259 |
| Notice date | Jun 14, 2004 |
| Establishment registration | 1220452 |
| FEI number | 1220452 |
At a glance
- 10–99 Supplements
- Jul 26, 2024 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- No Withdrawn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: