Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON, HEALON GV/HEALON 5 SODIUM HYALURONATE OPHTHALMIC VISCOSURGICAL DEVICES

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Absorb GTi Bioresorbable Vascular Scaffold (BVS) System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COMFILCON A SOFT (HYDROPHILIC) CONTACT LENSES

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 630G SYSTEM WITH SMARTGUARD

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDESIGN Refractive Studio

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas AmpliPrep/cobas TaqMan HBV Test, v2

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm Voluma XC

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

FDA Pre-Market Approval

FDA Class 3 ·VISITAG SURPOINT External Processing Unit (EPU)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SmartAblate™ Irrigation Tubing Set

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI

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

FDA Pre-Market Approval

FDA Class 3 ·Natrelle Silicone-Filled Breast Implants

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata and Optisure

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent System - RX and OTW

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 630G System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND