Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT)

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Navitor Transcatheter Aortic Heart Valve

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·WOLVERINE Coronary Cutting Balloon

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN, INOGEN, ORIGEN, AUTOGEN EL ICD; DYNAGEN MINI, INOGEN MINI, ORIGEN MINI ICD; INCEPTA, ENERGEN, PUNCTUA ICD; MOME

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

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

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

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

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTAPRO™ and Rotalink Rotational Atherectomy System

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG and Relia IPG

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·Parvovirus B19 IgM Enzyme Immunoassay

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Ability Lead

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG, ENPULSE E1 IPG,ENPULSE E2 IPG, KAPPA D(KAPPA 700)IPG, KAPPA D(K

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

FDA Pre-Market Approval

FDA Class 3 ·BRAVA CRT-D,BRAVA QUAD CRT-D,VIVA QUAD S CRT-D,VIVA QUAD XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D,CRT-D MRI AMPLIA,CRT-D MRI