Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Angio Seal Vascular Closure Device

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HM II LVAS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·PHOTOFRIN 630 PDT LASER

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·SUPERION INTERSPINOUS SPACER

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·Barostim System

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554

Lens, Intraocular, Accommodative

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (AIOL), MODELS AT-45-HD100, HD500, AND HD520

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF CRT-D SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MICRA

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ARCTIC FRONT CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ST CARDIAC

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Upper Airway Stimulator

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·Ambicor Inflatable Penile Prosthesis (IPP), AMS 700 IPP

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System