Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CYLOS , PHILOS, PHILOS II, EVIA, ENTOVIS, EURO EFFECTA, ESTELLA FAMILY

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

FDA Pre-Market Approval

FDA Class 3 ·LUMAS FAMILY

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC RESTORE FAMILY IMPLANTABLE NEUROSTIMULATORS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATORS (IPG) PRODUCT FAMILY

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LEXOS DR/VR(-T) ICDS & LUMOS VR/DR (-T) & XELOS DR-T ICD & BELOS DR (-T) ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC AIRBAG (-T) ICDS & BELOS VR (-T) ICDS & TMS 1000 PLUS PROGRAMMING SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CYLOS PACEMAKER & PHILOS II PACEMAKERS & ICS 3000 IMPLANT CONTROL SYSTEM & IMPLANT MODULE

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series, AED Pro, Propaq MD

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED 3, AED Plus

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATORS (IPG)

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim THerapy System, Verify Evaluation System

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Restore, Itrel, Synergy and Intellis; Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cor

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·BELOS, CARDIAC AIRBAG, LEXOS, AND XELOS FAMILIES OF ICDS