2,340 results · 22ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Mirro MRI DR, Mirro MRI VR, Primo MRI DR, P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Mirro MRI DR, Mirro MRI VR, Primo MRI DR, P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IMG, Astra S DR MRI IG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra X

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Percepta Quad CRT-P MRI SureScan, Percepta CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, Serena CRT-P MRI SureScan

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ASTRA XT SR MRI SURESCAN, ASTRA XT DR MRI SURESCAN, ASTRA S SR MRI SURESCAN, ASTRA S DR MRI SURESCAN, SOFTWARE MODEL

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Compia MRI CRT-D DTMC1D4; Compia MRI Quad CRT-D DTMC1QQ

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Advisa DR/Advisa DR MRI/Advisa SR MRI IPG

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Claria MRI/Claria MRI Quad CRT-D SureScan devices

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA DR IPG; DR MRI IPG; SR MRI IPG

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Sprint Quattro Secure S MRI & MRI SureScan Leads

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA DR IPG, DR MRI IPG, SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Advisa DR MRI and Advisa DR/DR MRI IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI ICD,Cobalt XT MRI ICD,Crome MRI ICD,Evera MRI DF-1 ICD,Evera MRI ICD,Evera S DR ICD,Evera S VR ICD,Evera XT D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG