Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·TRIFECTA VALVE

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY LEADS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PRMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (CMS)

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA/VISTA FAMILIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX & VENTAK MINI ICD: LATTITUDE PATIENT MANAGMENT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FLEXABILITY ABLATION CATHETERS (UNI-DIRECTIONAL),FLEXABILITY ABLATION CATHETERS (BI-DIRECTIONAL)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL 3/SYNERGY/SYNERGY VERSITREL IPG/RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RESTOREADVANCED INS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME, SV, LL; XIENCE Xpedition, SV, LL; Everolimus Eluting Coronary Stent Systems;XIENCE Alpin and Sierra Everol

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART SD, LINOX SMART S, VOLTA 1CR, VOLTA 2CR

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX NOVUS LEAD,VITATRON CRYSTALLINE LEAD

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN PERFORMA MODEL 4298 LEAD