Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve TM EvolutTM R Transcatheter Aortic Valve, Medtronic CoreValveTM EvolutTM PRO Transcatheter Aortic V

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt

Stent, Carotid

FDA Pre-Market Approval

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

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·INTRASTENT DOUBLESTRUT STENT

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre 14 day Flash Glucose Monitoring System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Sodium Hyaluronate Ophtalmic Viscoelastic Devices (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Core Valve™ Evolut™ R Transcatheter Aortic Valve, Medtronic Core Valve™ Evolut™ Pro Transcatheter Aortic Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtronic Evolut FX Transcatheter Aortic Valve; Medtronic Evolut FX+ T

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·DUETT PROSEALING DEVICE (MODEL 1010), DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210), AND D-STAT FLOWABLE HEMOSTAT...

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE NITINOL STENT SYSTEM & PRECISE RX NITINOL STENT SYSTEM & PRECISE PRO RX NITINOL STENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Sys

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·DIAGNOSTIC DUETT SEALING DEVICE, MODEL 2200; DIAGNOSTIC DUETT PRO SEALING DEVICE, MODEL 2210; AND D-STAT FLOWABLE HEMOS0

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve™ Evolut PRO System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs