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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·2490D/E CARELINK MONITORS & MODEL 2491 DDMA SOFTWARE FOR INSYNC MARQUIS & MAXIMO VR/DR CAPABILITY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE LP Cervical Disc

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER PFO OCCLUDER

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Tendyne Transcatheter Mitral Valve System

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip G4 System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system

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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INSYNC MAXIMO MODEL 7304 AND MODEL 7303

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VISUMAX FEMTOSECOND LASER

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·2490D/E CARELINK MONITORS

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx DownStream System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490G CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES