HEARTSTART 2000

FDA 510(k)

FDA Class 3 ·Cardiovascular

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Synergy Ablation System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO Models L100, L101, L121; PROPONENT Models L200, L201, L221; ACCOLADE Models L300, L301, L321; PROPONENT MRI Mod

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SUBCURANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCON G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval

FDA Class 3 ·EVOQUE Transcatheter Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS ELUTING CORONARY STENT

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ATTUNE Revision Femoral Sleeves

Tissue Adhesive Internal Use

FDA Pre-Market Approval

FDA Class 3 ·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Tissue Adhesive Internal Use

FDA Pre-Market Approval

FDA Class 3 ·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Tissue Adhesive Internal Use

FDA Pre-Market Approval

FDA Class 3 ·LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval

FDA Class 3 ·Vivistim® System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS®) Liver™

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

FDA Pre-Market Approval

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

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·TheraSphere

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER OPEN-IRRIGATED ABLATION CATHETER

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·INTERGEL ADHESION PREVENTION SOLUTION