Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Model 2580 Patient Remote

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II HTD / Blazer Prime HTD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·S-ICD GEN 2, S-ICD EMBLEM MRI

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·Wallstent Venous Endoprosthesis with UNISTEP Plus

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·St. Jude Medical Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valves Graft

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·Esteem System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead and Attain OTW LV Lead

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Respiratory Sensing Lead and Inspire Stimulation Lead

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE SYSTEM

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY/PLUS LEAD/STRAIGHT LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN, ORIGEN; ICD'S

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MYOCARDIAL PACING LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, CONTAK CD 2, EASYTRAK, EASYTRACK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accolade Pacemakers

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Sphera DR MRI IPG

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

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