Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense® E3 Continuous Glucose Monitoring (CGM) System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) PRODUCT

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense® E3 Continuous Glucose Monitoring (CGM) System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed iPro2 CGM System with Elite Sensor

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro™ 2 CGM System with Enlite™ Glucose Sensor

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 system); t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Liberta RC Deep Brain Stimulation Implantable Pulse Generator

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Eterna Spinal Cord Stimulation Implantable Pulse Generator

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

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN / INOGEN / DYNAGEN / AUTOGEN / MOMENTUM / VIGILANT / RESONATE / Implantable Cardiac Resynchronization Therapy Def

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ALTRUA 2 / ESSENTIO / PROPONENT / ACCOLADE / Accolade Non-MRI Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI / PROPONENT MRI /ACCOLADE MRI / Accolade MRI Pacemakers

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·VALITUDE / VALITUDE X4 / VISIONIST / VISIONIST X4 / Accolade C ardiac Resynchronization Therapy-Pacemaker (CRT-P) Device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN / INOGEN / DYNAGEN /AUTOGEN /MOMENTUM /VIGILANT/ PERCIVA / RESONATE/ Implantable Cardioverter Defibrillator (ICD)

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN MINI, INOGEN MINI, ORIGEN MINI and PERCIVA MINI

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

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

FDA Pre-Market Approval

FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

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 ·iPro2 Continuous Glucose Monitoring (CGM) System with Enlite System