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 ·ENRHYTHM IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II, PROTECTA, PROTECTA XT, SECURA VIRTUOSO II

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SECURA DR/VR/VIRTUOSO DR/VR ICD/MAXIMO II DR/VR/VIRTUOSO II VR/DR

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MYOCARDIAL PACING LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW AND OTW LV LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02, W4TR02; Solara Bipolar CRT

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·Sphere-9 Catheter and Affera Ablation System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Carelink SmartSync™ Platform Carelink SmartSync TM Common Application

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacemaker System

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain StarFix Lead

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia/Claria/Compia MRI QUAD CRT-D, Brava CRT-D, Brava Quad CRT-D, Compia MRI CRT-D,Consulta/Protecta

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Syncra CRT-P

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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

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/Maximo II/Secura DR/Serura/Virtuoso II DR/VR/Visi

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 Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VITATRON SOFTWARE MULTIPLE SOFTWARE MODELS