Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve Evolut R System and CoreValve Evolut PRO System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve System/ Evolut R System/ Evolut PRO System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon GV PRO

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EnVeo R and EnVeo PRO delivery catheter system (DCS)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Evolut PRO+ System and Medtronic Evolut FX System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve Evolut R System and CoreValve Evolut Pro System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GST (MINILINK TRANSMITTER) & GSR (CGMS I PRO RECORDER)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series, R Series, Propaq MD, and AED Pro

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve Evolut R System and CoreValve Evolut PRO System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Core Valve Evolut R and PRO R System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENTS SYSTEMS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE, PRECISE RX AND PRECISE PRO RX NITINOL STENT SYSTEM

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·lntraStent DoubleStrut Stent, Visi-Pro Balloon-Expandable Peripheral Stent System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System