Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA, ENERGEN INCEPTA COGNIS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN AND ORIGEN CRT-DS

FDA Pre-Market Approval

ORIGEN, ORIGEN X4,DYNAGEN,DYNAGEN X4,INOGEN,INOGEN X4 CRT-DS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3

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

FDA Pre-Market Approval

FDA Class 3 ·HeartLogic™

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS/LIVIAN/CONTAK RENEWAL/CONTAK RENEWAL 3 RF

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS FAMILY

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD/CD2/RENEWAL/EASYTRAK

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SUTURE SLEEVE ACCESSORY

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

FDA Pre-Market Approval

FDA Class 3 ·NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D). DYNAGEN CRT-D, X4 CRT-D; INOGEN CRT-D, X4 CRT-D; ORIGEN CRT

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

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

FDA Pre-Market Approval

FDA Class 3 ·Latitude™ NXT Patient Management System (COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE,

FDA Pre-Market Approval

DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA ICD'S

Enzyme Immunoassay, Phenobarbital

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Phenobarbital

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA classification

FDA Class 3 ·Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Pacemaker/Icd/Crt Non-Implanted Components

FDA classification

FDA Class 3 ·Pacemaker/Icd/Crt Non-Implanted Components

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

FDA classification

FDA Class 3 ·Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

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

FDA classification

FDA Class 3 ·Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Implantable Cardioverter Defibrillator (Non-Crt)

FDA classification

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-Crt)