Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

FDA Pre-Market Approval

FDA Class 3 ·Thoraflex™ Hybrid

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith Dissection Endovascular System

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval

FDA Class 3 ·Guardian System

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

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MemoryGel Enhance Breast Implants

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Minima Stent System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag™ Circulatory Support System

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·AGENT Paclitaxel-Coated Balloon Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G Pump, MiniMed 770G Pump, Guardian Link (3) Transmitter, Guardian Sensor (3), Contour Next Link 2.4 Meter, R

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline™ Vantage Embolization Device with Shield Technology™

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·MemoryGel Enhance Silicone Breast Implants

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY+

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED®) System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA® Redensity, RHA® Redensity Mepi

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

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Cobalt, Crome App, Cobalt XT MRI CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt XT MRI ICD