Stimulator, Electrical, Implanted, For Essential Tremor

FDA Pre-Market Approval

FDA Class 3 ·Vercise PC, Vercise Gevia and Vercise Genus DBS Systems

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems

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

FDA Pre-Market Approval

FDA Class 3 ·QUADRIPOLAR PACING PAS (QUAD PAS)

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

FDA Pre-Market Approval

FDA Class 3 ·MT PAS ACUITY X4

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PAS LACROSSE TM PTCA CATHETER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 3-PCS MONOFOCAL LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PAS CHAMPION HP PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PROGRESSIVE ANGTIOPLASTY SYSTEMS (PAS) CHAMPION PTCA CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·EXTENSION TO THE PAS LACROSSE PTCA CATHETER PRODUCT LINE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programmer Software

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Inspiris Resilia Aortic Valve

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·Hydrus Microstent

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·INSPIRIS RESILIA Aortic Valve, Model 11500A