Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Essentio MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent, Accolade MRI SR, Accolade MRI DR and Accolade MRI EL DR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Compai MRI Quad/Consulta/Maximo II/Pro

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR, DR MRI, and SR MRI IPG, Astra S DR MRI, S SR MRI, XT DR MRI, and XT SR MRI IPG, Azure S DR MRI, S SR MRI, XT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Tendril MRI, Assurity MRI, Endurity MRI family of Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO VALITUDE MRI, PROPONENT VALITUDE MRI, ACCOLADE VALITUDE MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Endurity MRI PM1172, PM2172; Assurity MRI PM1272, PM2272; Zenex MRI PM1282, PM2282; Zenus MRI PM1182, PM2182; Accent MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICVD, Primo MRI VR ID, Visia AF MRI

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Attesta DR MRI SureScan, L DR MRI SureScan, S DR MRI SureScan, SR MRI SureScan, Sphera DR MRI SureScan, L DR MRI SureSca

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI and Amplia MRI Quad CRT-D SureScan , Compia MRI and Compia MRI Quad CRT-D SureScan, Claria MRI and Claria MRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI AND ENRHYTHM MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Endurity MRI, and Assurity MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Endurity MRI ,Assurity MRI Pacemaker

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI