Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech's Automated External Defibrillator (AED) System

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)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ICS 3000/EDP 30/CARDIOMESSENGER

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Mentor MemoryShape® Silicone Gel-Filled Breast Implant PMA

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Mentor MemoryGel® Silicone Gel-Filled Breast Implant PMA

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·SNS URINARY NEUROSTIMULATORS IMPLANTABLE INTERSTIM

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·HV Steroid Eluting Cardiac Leads

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

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

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEXGEN COMPLETE KNEE SOLUTION/LEGACY KNEE - POSTERIOR STABILIZED (LPS)/LPS-FLEX MOBILE BEARING KNEE

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS