Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM & SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve Evolut R System, CoreValve Evolut PRO System, and CoreValve Evolut PRO + System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form

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

FDA Pre-Market Approval

FDA Class 3 ·Tendril ST Lead, OptiSense, Tendril STS Lead and Tendril STS Lead (MR Conditional)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TACHOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND PROGRAMMER SOFTWARE VERSION A-K00.1.U/5

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS PREMIER & PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Prostar XL Percutaneous Vascular Surgical System and Perclose ProGlide Suture-Mediated Closure System

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, and Origen Implantable Cardioverter Defibrillators (ICD

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL DX, MODELS 1388 T/K & TENDRIL SDX MODELS 1488 T/K

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE MR CORONARY STENT SYSTEM & TAXUS LIBERTE OTW CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Resonate, Momentum, Vigilant, Autogen, Dynagen, Inogen, and Origen Cardiac Resynchronization Therapy Defibrillators (CRT