Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASOSEAL (TM)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODELS 925, 2040, 2041, 6564

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip System (NTR and XTR)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK LEAD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD System

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval

FDA Class 3 ·INTERTACH(R) II IMPLANT. PACEMAKER PULSE GENERATOR

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

FDA Pre-Market Approval

FDA Class 3 ·EPT-1000 XP RF ABLATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN HE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC ABLATION CATHETERS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTERS MECHANICAL HEART VALVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM™ S-ICD Model A209; EMBLEM™ MRI S-ICD Model A219

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Reliance 4-Front Leads, Suture Sleeve Accessory for Reliance 4-Front Leads, Endotak Reliance 4-Site Leads and Endotak Re

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

FDA Pre-Market Approval

FDA Class 3 ·TactiCath Contact Force Ablation Catheter, Sensor Enabled

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN / INOGEN / DYNAGEN /AUTOGEN /MOMENTUM /VIGILANT/ PERCIVA / RESONATE/ Implantable Cardioverter Defibrillator (ICD)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD INTRAOCULAR LENS (IOL)/SOFTEC I IOL/SOFTEC HD PS IOL

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Navitor Transcatheter Aortic Valve Implantation System, Navitor Transcatheter Aortic Heart Valve, FlexNav Delivery Syste

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASOSEAL VHD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM DR/VR AICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN PULSE GENERATORS