Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·AORTIC VALVED GRAFT WITH MEADOX(R) HEMASHIELD(R)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE S MRI SURESCAN ; SPRINT QUATTRO SECURE MRI SURESCAN

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM

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)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE Wave Communicators

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Veify Evaluation System (SNS Bowel Programming Systems)

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Performa Lead and Attain Stability Quad MRI Lead

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve, Medtronic Evolut™ PRO+ Transcatheter Aortic Valve, Medtroni

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

FDA Pre-Market Approval

FDA Class 3 ·Intella Tip MiFi XP cardiac ablation catheters

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCEPTA,ENERGEN,PUNCTUA,TELIGEN IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATORS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II IMPLANTABLE INFUSION PUMPS/INTRA-ARTERIAL VASCULAR CATHETERS/VASCULAR CATHETERS/INDURA 1P INTRATHECAL CATH

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/VIRTUOSO II

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK LEAD SYSTEM FAMILY