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, Compia

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

FDA Pre-Market Approval

FDA Class 3 ·INVIVE CRT-P AND ZOOMVIEW PROGRAMMER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·BIOTRONIK ICD FAMILIES

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·DRIVER & MICRODRIVER CORONARY STENT SYSTEMS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain StarFix Lead

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

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II Steroid-Eluting Pacing Leads

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and 3 IN.PACT 018 Paclita

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE CS/SVC LEAD

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip G4 System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant, Endurant II, Endurant IIs

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Ranger Over-The-Wire Paclitaxel-Coated PTA Balloon Catheter

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Coseal Surgical Sealant

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI LEAD, REVO MRI SURESCAN IPG

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

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS