PMA
P110040: MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM
FDA PMA · STENT, SUPERFICIAL FEMORAL ARTERY · Medtronic Vascular
Key facts
| PMA number | P110040 |
|---|---|
| Trade name | MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Medtronic Vascular |
| Owner/operator | Medtronic, Inc. |
| Product code | NIP |
| Approval date | Sep 19, 2013 |
| Docket number | 13M-1159 |
| Notice date | Sep 23, 2013 |
| 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- Yes Withdrawn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: