Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA FAMILY OF LEADS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF CRT-D SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ELLIPSE FAMILY OF ICDS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current+, Fortify, Fortify Assura, Ellipse, Promote+

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

FDA Pre-Market Approval

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

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

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

FDA Pre-Market Approval

FDA Class 3 ·Tendril SDX, OptiSense, Tendril STS and Tendril ST Low Voltage Active Fixation Leads

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic™, Epic™ Supra and Epic™ Plus Tissue Heart Valves, Biocor™ and Biocor™ Supra Tissue Heart Valves

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE/CURRENT/FORTIFY FAMILIES OF ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·ANTHEM, ALLURE/RF, ALLURA QUADRA/RF FAMILY OF CRT-P'S

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE FIXATION SJ4 LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PROTEGE NEUROSTIMULATION SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER

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

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DURATA, DURATA, OPTISURE