Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ICS 3000/EDP 30/CARDIOMESSENGER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Azure Astra App

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HearCare MED-EL, MAESTRO System Software 10.0

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Percepta Serena Solara App

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG IPG Clinical Programmer App

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 31301 CARELINK EXPRESS APP.

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG. ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, ENOUKSE E2 IOG, KAPPA D IPG,KAPPA DR IP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI ICD, S DR ICD, S VR ICD, XT DR ICD, ST VR ICF, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECT ICD, S

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

FDA Pre-Market Approval

FDA Class 3 ·BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D; MAXIMO II CRT-D, PROTECTA CRT-D, PROTECT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RENO MRI SURESCAN IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Visia AF App, CareLink SmartSync Evera MRI App, CareLink SmartSync Viva Consulta Syncra Advisa Ensura

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

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Claria Amplia Compia App, CareLink SmartSync Cobalt, Crome App, CareLink SmartSync Viva Brava Evera A

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS) External Programmer Apps

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SPINAL CORD STIMULATION (SCS) EXTERNAL PROGRAMMER APPS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DEEP BRAIN STIMULATION (DBS) EXTERNAL PROGRAMMER APPS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta/Versa/Sensia, Advisa DR/DR MRI/SR MRI, EnPulse E1/E2, Kappa DR (Kappa 700/600, 900/800)/VDD (Kappa 700) families

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync