5353 Wayzata Blvd Suite 400, St Louis Park, United States, 55416
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Enterra II Neurostimulator | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Enterra II Neurostimulator Model 37800 | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Enterra Unipolar Lead Kit | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Enterra Unipolar Lead Kit Model 4351-35 | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
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