Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Lotus Edge Valve System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, SPhera DR MRI IPG, and Sphera SR MRI IPG

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·WOLVERINE Coronary Cutting Balloon

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense Lead

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Misago RX Self-expanding Peripheral Stent

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Amulet Left Atrial Appendage Occluder

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP NOVUS & SENSE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·4EDTRONIC(R) HALL PROSTHETIC HEART VALVE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VOYAGER RX CORONARY DILATATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ELLIPSE FAMILY OF ICDS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION (TAXUS ELEMENT CORONARY STENT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Low Voltage Active Fixation Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata and Optisure High Voltage Lead

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI PROPONENT MRI and ACCOLADE MRI