Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·IPRO2 CGM SYSTEM WITH ENLITE SENSOR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·nGEN Pump

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA INTAOCULAR LENS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Expandable Introducer Sheath Set

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Tendril SDX, OptiSense, Tendril STS, Tendril ST

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II Cooled Ablation Catheter and Cable

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA Anterior Chamber Intraocular Lenses

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 PharmDx

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·Apollo Onyx Delivery Micro Catheter, 1.5cm, Straight/Apollo Onyx Delivery Micro Catheter, 3.0cm, Straight

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere (comfilcon A), Biofinity Toric

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

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre 14 day Flash Glucose Monitoring System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant Stent Graft Family

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Tendril MRI leads (MRI)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Ovation iX Abdominal Stent Graft System