Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·EPi-Sense Guided Coagulation System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·BioMimics 3D Vascular Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avanta, Neutrino NXT, Gallant, Entrant VR ICD and Avant, Neutrino, Gallant and Entrant DR ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

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, RELIA IPG

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval

FDA Class 3 ·Venaseal Closure System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Advanced Valve Metal (AVM) capacitor

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II™ Left Ventricular Assist System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Latitude™ NXT Patient Management System (EMBLEM S-ICD)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROTECTA + PROTECTA XT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX

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

FDA Pre-Market Approval

FDA Class 3 ·TactiCath Quartz Set