Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COSMOS(TM) SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL Platinum CHromum Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·FlexAbility Ablation Catheter / FlexAbility Ablation Catheter Sensor Enabled

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello S 45/53/60, Solia S 45/53/60, Siello T 53/60, Siello JT 45/53, Solia T 53/60, Solia JT 45/53, EFH-6F-W

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·Abre Venous self-expanding stent system

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova Vascular Self Expanding Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX,CAPSUREFIX NOVUS, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Astron Pulsar Stent System, Pulsar-18 Stent System

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT CAPTIVIA STENT GRAFT SYSTEM

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(TM) ECD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENRHYTHM / ENRHYTHM MRI

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II TEMPERATURE ABLATION CATHETERS AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS USED WITH MAESTRO 3000 CARI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CHORUS PACEMAKERS