System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LVAS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·R1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER LEGEND RX BALLOON DILATATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION/SCORPION M/SCORPION *2/SCORPION *2 M ABLATION CATHETERS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VASCULAR DRIVER MX2 CORONARY STENT SYSTEM& MIRCODRIVER MX2 CORONARY STENT SYSTEM

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·S-ROM POLY-DIAL CONSTRAINED LINER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) Systems

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MiniMed iPro2 CGM System with Enlite Sensor

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G System

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI APOLLO RELY OVER-THE-WIRE BALLON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE