Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AICD SYSTEM. PRESCRIPTOR PROGRAMMER AND PROGRAM AND PROGRAM DISK

Prosthesis, Testicular

FDA Pre-Market Approval

FDA Class 3 ·Torosa Saline Filled Testicular Prosthesis

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON MINI NEUROSTIMULATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF CRT-DS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AID-B/BR AND VENTAK ICD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD CRT-D &EASYTRAK CORONARY VENOUS STEROID ELUTING SINGLE ELCTRODE PACE/SENSE LEAD

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

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

FDA Pre-Market Approval

FDA Class 3 ·Fineline II Sterox, Sterox EZ pace / sense leads

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith Alpha™ Thoracic Endovascular Graft

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR, INVIVE, INTUA FAMILIES OF CRT-PS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/ Quadrip

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX, VENTAK MINI FAMILIES OF ICDS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS 1-Piece OptiBlue IOL, Preloaded TECNIS 1-Piece IOL, TECNIS Multifocal 1-P

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBe

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FLEXTEND PACING LEADS AND FIXATION TOOL

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·HBeAg Reagent Pack and Calibrator

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous Implantable Defibrillator (S-ICD) System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBs / Elecsys HBs II