Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TUNNELING TOOL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC PULSE GENERATOR; INSYNC III

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacing System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RENO MRI SURESCAN IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 DR/SR IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-P/INSYNC III CRT-P

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ATAKR II MODEL 4802 (60W) SOFTWARE VERSION 1.36

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG, ADAPTA DR IPG, ADVISA DR MRI IPG, ADVISA DR MRI IPG, RELIA IPG,

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, and Sensia IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG,

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P,Solar Bipolar CRT-P,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 DR/SR/ REMOTE ASSISTANT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VITATRON T60 DR AND T20 SR SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI LEAD

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·INSYNC & INSYNC III CRT-P