Medtronic Cardiac Rhythm Disease Management

8 devices 8 registrations
✕ UK (MHRA) ✕ EU (EUDAMED) ✕ Canada (Health Canada) ✕ AU (TGA)
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Devices

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Device Name US UK CA AU EU
BYREL PROGRAMABLE PACEMAKER 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)
CapSure Sense Lead (4074), CapSure Sense Lead (4574), Vitatron Crystalline Lead (ICM09B, ICM09JB) 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)
CAPSURE/SP/Z NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II 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)
Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome MR 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)
Evera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S 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)
MEDTRONIC PCD TACHYARRHYTHMIA CONTROL 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)
MODEL 5441 EPG PLASTIC COVER 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)
SelectSecure Lead (3830) 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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