Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ATTAIN ABILITY MRI SURESCAN, ATTAIN PERFORMA MRI SURESCAN LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Torque Wrench

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SJM MRI Activator

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T,PHILOS II DR-T,CYLOS DR-T,EVIA DR-T/EVIA SR-T,ENTOVIS DR-T/ENTOVIS SR-T,ESTELLA DR-T/ESTELLA SR-T

Ventricular (Assist) Bypass

FDA Pre-Market Approval

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Evolut R Transcatheter Aortic Valve System, Evolut PRO Transcatheter Aortic Valve System, Evolut PRO+ Transcatheter Aort

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems

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,

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Anchoring Sleeve Kit, SelectSecure Lead

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC COREVALVE SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK 35 monitor/defibrillator

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY SR/DR

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Invive, Intua, Visionist, Valitude