Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain StarFix Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSure Fix MRI Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Syncra CRT-P, and Viva CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF2 IC

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacemaker System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

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

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Syncra CRT-P and Viva CRT-P

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPI UNIPOLAR & BIPOLAR LEAD

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA RC DEEP BRAIN STIMULATOR

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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·Abre™ Venous Self-expanding Stent System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtronic Evolut FX Transcatheter Aortic Valve; Medtronic Evolut FX+ T