Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MYOCARDIAL PACING LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA IPGS/ C & T SERIES IPGS

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacing System (TPS)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 700/650/600, KAPPA 900/800 AND ENPULSE E1/E2

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, Solara Bipolar CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA+ C & T SERIES IPGS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VIATRON C20 SR IPG, VITATRON C60 DR IPG, VIATRON T20 SR IPG, VIATRON T60 DR IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DA+C & DA+T SERIES

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Sprint Quattro Lead; Subcutaneous Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC & INSYNC II CRT-P

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Tunneling Tool

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain StarFix Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolara CRT-P, Sol

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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