Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA Pre-Market Approval

FDA Class 3 ·NeuRX Diaphragm Pacing System (DPS)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMP DPS SOFTWARE

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMP DPS SOFTWARE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Endurity, Assurity, Endurity Core, Zenus, Zenex

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval

FDA Class 3 ·Vivistim® System

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HEALTHTRONICS OSSATRON

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HEALTHTRONICS OSSATRON

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval

FDA Class 3 ·Vivistim® System

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval

FDA Class 3 ·MicroTransponder Vivistim Paired VNS System (Vivistim System)

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HEALTHTRONICS OSSATRON

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ADHESION CONTROL IN A BARRIER GEL

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval

FDA Class 3 ·Vivistim System

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HEALTHTRONICS OSSATRON

Stimulator, Functional Neuromuscular, Scoliosis

FDA Pre-Market Approval

FDA Class 3 ·SCOLITRON(TM) STIMULATOR