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

FDA Pre-Market Approval

FDA Class 3 ·THINLINE II STEROX, FINELINE II STEROX & FINELINE II STEROX EZ LEADS

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER, AND AMPLATZER ¿CRIBRIFORM¿ OCCLUDER

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Navitor Transcatheter Aortic Valve Implantation System; Navitor Transcatheter Aortic Heart Valve; FlexNav Delivery Syste

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2920 (PRM) SYSTEM ZOOM (VENTAK AV AICD SYSTEM)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AICD SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD, BLAZER II, BLAZER II HTD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) EMBLEM S-ICD/MRI S-ICD

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

FDA Pre-Market Approval

FDA Class 3 ·Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, Visionist X4 CRT-P

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II/BLAZER PRIME HTD ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT )

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK/VENTAK P/VENTAK P2 FAMILIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Pervica

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

FDA Pre-Market Approval

FDA Class 3 ·CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST, and VALITUDE

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer™ Muscular VSD Occluder

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI SR, ESSENTIO MRI DR, PROPONENT MRI SR, PROPONENT MRI DR, ACCOLADE MRI SR, ACCOLADE MRI DR, INGEVITY PLUS AF

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MOBILEXCIMER FOR PTK AND PRK

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software