Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EAZ101 / Epsila EV Sternal Tunneling Tool, EAZ201 / Epsila EV Transverse Tunneling Tool

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV ICD

Stimulator, Neuromuscular, Implanted

FDA classification

FDA Class 3 ·Stimulator, Neuromuscular, Implanted

Orthosis, Pneumatic Structure, Rigid

FDA classification

FDA Class 3 ·Orthosis, Pneumatic Structure, Rigid

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA classification

FDA Class 3 ·Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

FDA classification

FDA Class 3 ·Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat

FDA classification

FDA Class 3 ·Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat

Stimulator, Functional Neuromuscular, Scoliosis

FDA classification

FDA Class 3 ·Stimulator, Functional Neuromuscular, Scoliosis

Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat

FDA classification

FDA Class 3 ·Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS and Micra TPS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ENPULSE INPLANTABLE PULSE GENERATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) TRANSVENE LEAD SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW/Attain OTW LV Lead; Consulta/Percepta Bipolar/Percepta Quadripolar/Serena Bipolar/Serena Quadripolar/

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Implantable Pulse Generator, Pacemaker (Non-Crt)

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 DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG,