Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·UNIPOLAR IS-1 CONNECTOR RECEPTACLE MODEL

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

FDA Pre-Market Approval

FDA Class 3 ·Valitude CRT-P IS1/IS4 EL, Visionist CRT-P IS1 El and Visionist CRT-P LV1 EL

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACUITY SPIRAL, EASYTRAK 2 LV-1, EASYTRAK 2 IS-1, EASYTRAK 3 LV-1, EASYTRAK 3 IS-1

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 2 LV-1 & IS-1, EASYTRAK 3 LV-1 & IS-1, AND ACUITY SPIRAL LEADS

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

FDA Pre-Market Approval

FDA Class 3 ·PG VALITUDE CRT-P IS1 EL, IS4 EL, PG VISIONIST CRT-P IS1 EL, LV1 EL, IS4 EL

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6998 IS-1 LEAD PORT PLUG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE IS -1 AND RELIANCE IS-4

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 & LV-1

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK IS-1 AND EASYTRAK LV-1 LEADS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ACUITY SPIRAL AND EASYTRAK 3 IS-1 LEADS

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

FDA Pre-Market Approval

FDA Class 3 ·H120 & H125 CONTAK RENEWAL TR IS-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Reliance 4-Front, 4-Site IS-1 Defibrillation

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 2 LV-1 AND IS-1 LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 2 LV-1, IS-1, 3 LV-1, 3 IS-1 LEFT VENTRICLAR HEART FAILURE LEADS, AND ACUITY SPIRAL LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Lead Cap (IS-1/DF-1/SJ4/DF/IS4) IS4/DF4 Port Plug; DF-1 Receptacle Plug; IS-1 Receptacle Plug

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·IS-1 CONNECTOR TERMINAL OF SELUTE/PICOTIP BIPOLAR LEADS