Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·UNIFY, UNIFY ASSURA, QUADRA ASSURA FAMILY OF CRT-D'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS + HF FAMILY OF CRT-DS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACCENT SR RF, ACCENT DR RF PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·ANTHEM RFCRT-PS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·FORTIFY AND PROMOTE QUANDRA FAMILY OF ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·UNIFY AND UNIFY QUANDRA FAMILY OF CRT-DS

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHOTON MICRO, EPIC, ATLAS, EPIC+, AND ATLAS+ FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus™ Deep Brain Stimulation (DBS) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Wave Writer Alpha TM Spinal Cord Stimulator (SCS) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Intellis Spinal Cord Stimulation Systems

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System