Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·LifeStent™ 5F Vascular Stent Systems

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE ICD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM & MARQUIS FAMILY ICD'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL ICDS/CRT-DS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI SURESCAN IPG AND PACING SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Spectranetics CVX-300 Exclimer Laser System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval

FDA Class 3 ·Venaseal Closure System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead, Attain OTW LV Lead

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5388 TEMPORARY PACEMAKER

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER, XTRA SURGICAL CRYOABLATION CATHETER, MAX SURGICAL CARDIAC CRYOABLATION CATHETER

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

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

FDA Pre-Market Approval

FDA Class 3 ·THERMACOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (MYNX PRODUCT FAMILY)

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO 3000 CARDIAC ABLATION SYSTEM