| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM. | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| CHORUS PACEMAKERS | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Reply SR, Reply DR | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| SITUS OTW UW28D LEADS | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
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