Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX CERAMIC HIP SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Epicardial Patch Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI, Cobalt XT MRI, Crome MRI ICD, Crome MRI ICD,Evera MRI DF-1,Evera MRI DF-1

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG,

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC (R) ELITE II PULSE GENERATOR

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO ABLATION CATHETER, SAFIRE BLU DUO ABLATION CATHETER AND 1500TP-CP V1.6 CARDIAC ABLATION GENERATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD-2 Lead, CareLink SmartSync Device manager Programmer and Vitatron Brilliant S+ VDD Lead

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Model 4340 Respiratory Sensing Lead

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·ELUVIA Drug-Eluting Vascular Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·Ampere™ Generator

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II PROGRAMMABLE INFUSION PUMP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA, ENERGEN, INCEPTA, AND TELIGEN ICD

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS.