Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Ingenio™ 2 CRT-P Devices; VALITUDE™ Model: U125; VALITUDE™ X4 Model: U128

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) TRANSVENE LEAD SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense MRI SureScan Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE IS-1/DF-1,RELIANCE 4-SITE PASSIVE FIXATION LEADS

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIC TARGIS SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL II, ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Upper Airway Stimulation Therapy

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain StarFix Lead

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Express LD Iliac Premounted Stent System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·INTELLANAV STABLEPOINT™ Ablation Catheter

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore Itrel and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads.

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Tacticath Contact Force Ablation Catheter, Sensor Enabled (Tacticath SE)