Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·EPIC AND EPIC+ DR/VR ICD SYSTEMS WITH N2 CAPACITOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS

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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INSYNC ICD MODEL 7272 AND MODEL 9969 APPLICATION SOFTWARE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/SECURA/VIRTUOSO/VIRTUOSO II ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 6/7 AND ILESTO/IFORIA ICD/CRT D FAMILIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ATLAS II/+, EPIC +/II/II+, CURRENT RF/+/ACCEL, FORTIFY ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA ICD FAMILIES

FDA Pre-Market Approval

CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX SD AND LINOX S FAMILY OF ICD PACING LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SECURA DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO ICDS

FDA Pre-Market Approval

INSYNC/CONCERTO/MAXIMO/CONSULTA FAMILIES OF ICDS & CRT-DS

FDA Pre-Market Approval

INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/INSYNC MARQUIS ICDS

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·PHOTON, EPIC, AND ATLAS FAMILIES OF ICDS AND CRT-DS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Pulse Generator (PG)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX LEAD/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO FAMILY OF ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-D/CONCERTO & VARIOUS INSYNC FAMILY OF ICDS