Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/ SENSIA

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

FDA Pre-Market Approval

FDA Class 3 ·Cobalt XT HF Quad CRT-D MRI SureScan, Coblat HF Quad CRT-D MRI SureScan, Cobalt HF CRT-D MRI SureScan, Crome HF QUad CRT

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Septal Occluder and Amplatzer Cribriform Occluder

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Interstim Therapy System, Verify Evaluation System (SNS Urinary)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·Valitude, Valitude X4, Visionist, and Visionist X4 Cardiac Resynchronization Therapy - Pacemaker (CRT-P)

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain StarFix Lead

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Upper Airway Stimulation System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP NOVUS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Left Ventricular Assist System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain StarFix Lead

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro

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

FDA Pre-Market Approval

FDA Class 3 ·Diamond Temp Catheter

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Myocardial Pacing Lead

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS