Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3 RF

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VAVLE

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX STEROID ELUTING LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM 2DR/VR AICD SYSTEMS & MODEL 2844, VERSION 3.1 SOFTWARE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Autogen, Dynagen, Inogen, Origen (NG3 ICDs), Momentum, Vigilant, Perciva, Resonate (NG4 ICDs)

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Muscular VSD Occluder

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE LEADS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic™ Supra Valve, Epic™ Valve, Epic™ Plus Stented Tissue Valve, Epic™ Plus Supra Valve, Epic™ Max Valve

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK MINI ACID FAMILY SYSTEMS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELUTE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·TACTICATH QUARTZ SET

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·D010 INOGEN™ MINI ICD VR, D011 INOGEN™ MINI ICD VR, D012 INOGEN™ MINI ICD DR, D013 INOGEN™ MINI ICD DR, D020 DYNAGEN™ MI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN ICD, INOGEN ICD, ORIGEN ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE G/SG LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX, VENTAK MINI