Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3550-31 SNAP-LID SCREENING CONNECTOR CABLE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK MINI II+ HE, MINI IV, MINI IV+ PULSE GENERATORS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

FDA Class 3 ·COSMAN ICP TELE-SENSOR(R)

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

FDA Class 3 ·ICP TELE-MONITOR & ICP TELE-SENSOR

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

FDA Class 3 ·COSMAN ICP TELE-SENSOR(R)

Electrode, Stabilized Epidural Spinal

FDA Pre-Market Approval

FDA Class 3 ·SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

FDA Class 3 ·COSMAN ICP TELE-SENSOR(R)

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

FDA Class 3 ·COSMAN ICP TELE-SENSOR(R)

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

FDA Class 3 ·COSMAN ICP TELE-SENSOR(R) & COSMAN

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis without InhibiZone™

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800™ Artificial Urinary Sphincter with and without InhibiZone™

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK CR2 Defibrillator

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG Implantable Pulse Generator

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Family of Implantable Pulse Generators

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim Family of Implantable Pulse Generators

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON A AND B SOFT CONTACT LENSES FOR DAILY AND EXTENDED WEAR

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

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE+, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY QUADRA, QUADRA ASSURA FAMI LIES OF CRT-D DEVICES