Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Tendril MRI Leads

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI SureScan Lead

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Azure XT SR / DR MRI SureScan, Azure S SR / S DR MRI SureScan , Software Model

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus MRI SureScan Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Device Command Library (DCL), CareLine Express

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·TRIFECA HEART VALVE

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

FDA Pre-Market Approval

FDA Class 3 ·remede System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·EPIC VALVE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Accent MRI Pacemaker

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ingevity + Lead - Active Fixation

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Sprint Quattro Secure S MRI SureScan Lead, Sprint Quattro Secure MRI SureScaan Lead and Sprint Quattro MRI SureScan Lead

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense MRI SureScan Lead

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO MRI SURESCAN LEAD MODEL 6946M

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

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE FIX NOVUS MRI SURESCAN LEAD MODELS 5076 AND 4076

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan and Implantable Pulse G

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·CYBERONICS VNS THERAPY