Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VICTORY PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER II CRT-PS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor Ablation System; Mara Water Vapor System; Mara Console

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System (SNS Urinary)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy, Intellis, Vanta, Sequentia LT, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System (SNS Bowel)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR SOFTWARE MODEL 9995

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A, AND MODEL 2491 DDMA

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD PREPSTAIN SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA SR MRI