Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC +

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

FDA Pre-Market Approval

FDA Class 3 ·ANTHEM FAMILY OF DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·Anthem, Allure/RF, Quadra Allure /RF family ofCRT-Ps

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA/RIATA ST/DURATA LEADS

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata, Optisure,

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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF CRT-D, and Entrant HF CRT-D

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim family of SCS IPGs

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

FDA Pre-Market Approval

FDA Class 3 ·Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure MP, Quadra Allure MP RF

Scaffold, Infrapopliteal, Absorbable

FDA Pre-Market Approval

FDA Class 3 ·Esprit™ BTK Everolimus Eluting Resorbable Scaffold System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·FORTIFY, FORTIFY ASSURA AND ELLIPSE ICDS

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF SYSTEM

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SlimTip DRG Trial Lead Kit, 50cm & 90cm / SlimTip DRG Implant Lead Kit, 50cm & 90cm / DRG Lead Extension Kit.

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+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs

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

FDA Pre-Market Approval

FDA Class 3 ·UNIFY AND UNIFY QUADRA CRT-D'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SOLUS,ADDVENT,SOLUS II,SYNCHRONY, PHOENIX III, TRIOLOGY, AFFINITY, INTEGRITY, ENTITY,IDENTITY, VERITY, AND VICTORY PACEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICES (ICD AND CRT-D)

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF CRT-D

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(TM)