Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE IS-1 FAMILY OF LEADS

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR IS-1 FAMILY

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6725 IS-1 PIN PLUG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE 4-SITE IS-4 LEADS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·UNIPOLAR IS-1 CONNECTOR RECEPTACLE MODEL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE IS-1 (PASSIVE) DEFIBRILLATION LEAD

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·UNIPOLAR IS-1 CONNECTOR RECEPTACLE MODEL

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE FAMILY OF LEADS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Various models of dual chamber ICDS in the Ilivia, Intica, Inlexa Families, Various models of CRT-Ds and Non- CRT-Ds in

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non implanted components PSW 1602.U, HMSC 3.34.0

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

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SPRINT LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

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

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 & LV-1

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