Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI

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

FDA Pre-Market Approval

FDA Class 3 ·Unify™, Unify Quadra™, Unify Assura™, Quadra Assura™, Quadra Assura MP™, Avant, Neutrino NxT, Gallant, Entrant

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CARELINK MONITOR MODEL 2490C AND MODEL 2491 DMA SOFTWARE

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

FDA Pre-Market Approval

FDA Class 3 ·Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP, Anthem

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity +, Endurity, Endurity Core, Zenus, Zenex, Accent

FDA Pre-Market Approval

CONCERTO ICD,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,BRAVA CRT-D,VIVA S

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO MODEL C154DWK

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Quad CRT-d; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, Quad CRT-D; Compia MRI CRT-D, Quad CRT-D; Viva

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D / Quad CRT-D; Brava CRT-D /Quad CRT-D; Claria MRI CRT-D / Quad CRT-D ; Compia MRI CRT-D / Quad CRT-D; V

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Quad CRT -D; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, Quad CRT-D; Compia MRI CRT-D, MRI Quad CRT-D;

FDA Pre-Market Approval

BRAVA CRT-D'S; BRAVA QUAD CRT-D'S; CONCERTO II CRT-D; CONSULTA CRT-D; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT

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

FDA Pre-Market Approval

FDA Class 3 ·MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT-

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

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-

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

FDA Pre-Market Approval

FDA Class 3 ·MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT-

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA CRT-D, COGNIS CRT-D, ENERGEN CRT-D, INCEPTA CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA CRT-DS, COGNIS CRT-DS, ENERGEN CRT-D'S, INCEPTA CRT-DS

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

FDA Pre-Market Approval

FDA Class 3 ·Amploa MRI CRT-D, Quad CRT-D, Brava CRT-D, Quad CRT-D, Claria MRI CRT-D, Quad CRT-D, Compia MRI CRT-D Quad CRT-D, Viva Q

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D & Quad CRT-D, Brava CRT-D & Quad CRT-D, Compia MRI CRT-D & Quad CRT-D, Concerto II CRT-D, Consulta CRT-

American Eagle Instruments

FDA UDI

AMERICAN EAGLE INSTRUMENTS, INC.·00841013106071·GRACEY 13-14 XP (3/8) BLUE