Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Septal Occluder and Amplatzer Cribriform Occluder

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Ellipse (MR Conditional)

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

FDA Pre-Market Approval

FDA Class 3 ·Quickflex u, Quartet Cardiac Resynchronization Therapy Passive

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic Plus, Epic Plus Supra and Epic Max Valves in the Epic Valve Sterilization Process

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS+ HF FAMILY OF CRT-DS

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER

FDA Pre-Market Approval

Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS+HF FAMILY OF CRT-DS

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip NT, NTR, and XTR Clip Delivery System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256,

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·S-SERIES LAMITRODE LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata, Optisure

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, FORTIFY, ELLIPSE ASSURA FAMILY OF ICD DEVICES

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories

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

FDA Pre-Market Approval

FDA Class 3 ·Allure. Allure Quadra