Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional)

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ACCULINK & RX ACCULINK CAROTID STENT SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Gallant, Entrant, Neutrino NxT Family of ICDs

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS + HF FAMILY OF CRT-DS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON NEUROSTIMULATION SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Tendyne Transcatheter Mitral Valve System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip G4 System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON, EON MINI AND PROTEGE IPG'S

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR, EPIC II/II+ DR/VR/HR, ATLAS, ATLAS+, AND ATLAS II/II+ ICD SYSTEMS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny family of Pacemakers

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(TM)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(TM)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura, Fortify

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, CURRENT ACCEL, CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICD DEVICES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY PULSE GENERATOR MODELS 235OL, 2250L, AND 2308L