FDA device listing
Endurant II AUI Stent Graft System,Endurant IIs Stent Graft System,Endurant II Stent Graft System,Endurant Stent Graft…
FDA device listing 1783538380 · Medtronic, Inc.
Key facts
| Proprietary names | Endurant II AUI Stent Graft System,Endurant IIs Stent Graft System,Endurant II Stent Graft System,Endurant Stent Graft System,Talent Occluder with Occluder Delivery System |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | P100021 |
| Product codes | MIH |
| Device names | MIH - System, Endovascular Graft, Aortic Aneurysm Treatment |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.MIH |
| Review panels | Cardiovascular |
| Registered establishments | Medtronic Distribution Center, MEDTRONIC IRELAND, MEDTRONIC MEXICO EG, Medtronic Mexico S. de R.L. de CV, Medtronic Vascular |
| Establishment registrations | 2953200, 9612164, 9617601, 3004497303, 3009380063 |
| FEI numbers | 3001452571, 3002534070, 3002806434, 3004497303, 3009380063 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database