Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP NT CLIP DELIVERY SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·REGENT/STANDARD/MASTERS MECHANICAL HEART VALVES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LD Ingevity Plus AF IS1

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VLAVES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD CARDIAC ABLATION CATHETERS & BLAZER PRIME HTD CARDIAC ABLATION CATHETER & STERILE CABLES

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Maestro 4000 Controller

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COSMOS(TM) SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD ADAPTERS MODEL NUMBER 6024

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Dynagen EL & Mini, Inogen EL & Mini, Origen EL & MIni IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK & RENEWAL FAMILIES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·RELAY/DASH/STRIDE/DART PACING SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO PG FAMILIES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONFIENT/VITALITY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·#2 BI-DIRETIONAL TORQUE WRENCH

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS CRT MODELS N118, N19