Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor, Arctic Front Advance (AFA) CryoAblation Catheters

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·External Paulse Generator (EPG) Patient Cable

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 COnnector Port Pin Plug Kit, Lead Ad

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacing System

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINLINE/FINELINE LEADS AND ACCESSORIES

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR...

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Model 3028 Implantable Pulse Generator (IPG)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUIDANT ZOOM PROGRAMMER

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·INSYNC ICD MODEL 7272

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA SR MRI

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO ICD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCTIC FRONT, ARCTIC FRONT ADVANCED, AND FREEZOR MAX CARDIAC CRYOABLATION CATHETERS