Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Gallant DR CDDRA500Q; Gallant VR CDVRA500Q; Neutrino NxT DR CDDRA800Q; Neutrino NxT DR CDDRA600Q; Neutrino NxT VR CDVRA8

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Brio Neurostimulation System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(TM)

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

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DURATA, RIATA ST OPTIM, RIATA ST, RIATA 8F

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System (LVAS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, CURRENT+, CURRENT ACCEL AND FORTIFY CRT-D'S

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 CORONARY STENT SYSTEM

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Aveir™ Delivery Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL), (UNI-DIRECTIONAL)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Portico™

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata and Optisure

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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM