Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·KINETRA & SOLETRA FAMILY OF NEUROSTIMULATORS

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia, Amplia MRI Quad, Brava, Brava MRI Quad, Claria MRI, Compia, Viva XT CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE (DRUG ELUTING) LEAD & PROGRAMMER ACCESSORY

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardiac Resynchronization Therpy Defibrillator (CRT-D): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN,

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-AUK PLUS assay

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Livewire TC Ablation Catheter, Livewire TC Cables, Safire Ablation Catheter, Safire Cables

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip NT Clip Delivery System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Spinal Cord Stimulation Systems

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO 2, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA PACEMAKERS; ADVANTIO, INGENIO, VITALIO, FORMIO (IPG)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SyncroMed Infusion System, Ascenda Intrathecal Catheter Product Code:LKK

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Epicardial Patch Lead/Upsizing Sleeve

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Autogen, Dynagen, Inogen, and Origen NG3 ICDs and Resonate, Momentum, Vigilant, and Perciva NG4 ICDs

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Ability Lead and Attain Performa Lead

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Laser Angle Measurement Tool for Open and Close Leaflet Angles Measurement

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System