PMA
P090006: COMPLETE SE VASCULAR STENT SYSTEM
FDA PMA · STENT, ILIAC · Medtronic Vascular
Key facts
| PMA number | P090006 |
|---|---|
| Trade name | COMPLETE SE VASCULAR STENT SYSTEM |
| Generic name | STENT, ILIAC |
| Applicant | Medtronic Vascular |
| Owner/operator | Medtronic, Inc. |
| Product code | NIO |
| Approval date | Mar 17, 2010 |
| Docket number | 10M-0158 |
| Notice date | Mar 26, 2010 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 10–99 Supplements
- Feb 1, 2017 Latest supplement decision
- Yes Withdrawn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: