Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 630G System with Guardian Sensor (3)

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

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Flash Glucose Monitoring System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 670G System with Guardian Sensor (3)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NexGen® LPS-Flex / LPS-Mobile Bearing Knee

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Connect System

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 670G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G System

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

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre 14-Day Flash Glucose Monitoring System

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Optune System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm REAL-Time Revel System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD PDA

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm REAL-Time Revel System