Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR TREATMENT OF BPH

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE and PROPONENT Pacemaker Devices

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

FDA Pre-Market Approval

FDA Class 3 ·Loctite® 4206™

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Scaffold, Infrapopliteal, Absorbable

FDA Pre-Market Approval

FDA Class 3 ·ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE, 1.3 CC AND 0.3 CC

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT DS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 COCHLEAR IMPLANT SYSTEM

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EMS-SWISS DOLORCLAST

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF CRT-D SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CHORUS PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS