Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MMT-7002 & MMT-7003 GLUCOSE SENSORS ( AUTOMATED BICARBONATE BUFFER TEST SYSTEM)

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINILINK TRANSMITTER, WATERTIGHT TESTER, MINILINK KIT WITH ENLITE SERTER AND MINILINK REPLACEMENT KIT

Gastric Emptying Breath Test

FDA Pre-Market Approval

FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·Guardian Sensor 3

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Pro Flash Glucose Monitoring System

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

FDA Pre-Market Approval

FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PRARDIGM REAL-TIME INSULIN PUMPS AND GUARDIAN REAL-TIME MONITOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G4 Platinum Continuous Glucose Monitoring System and Dexcom 5 Mobile Continuous Glucose Monitoring 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

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MYSENTRY SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME REVEL INSULIN PUMP

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 770G System