Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESES

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse VR DR, Fortify Assura VR DR

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with the ThermaFix

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled

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

FDA Pre-Market Approval

FDA Class 3 ·IsoFlex Low Voltage Passive

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer DS Bi-Directional Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiology Catheter

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity XR Toric (comfilcon A)

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Solesta Injectable Gel

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK SYSTEM VISIFLEX IS DELIVERY CATHETERS

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY PULSE GENERATOR MODEL DR 5370

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL PUMP, PARADIGM REAL-TIME PUMP, AND GUARDIAN REAL-TIME MONITOR

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT ADMIRAL DCB

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

FDA Pre-Market Approval

FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis, Models 305 and 310