Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve and Accessories

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline™ Vantage Embolization Device with Shield Technology™ (Pipeline™ Vantage)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Carpentier-Edwards Perimount Theon Percardial Aortic Biop

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PERIMOUNT Bioprosthesis, PERIMOUNT Magna Aortic Bioprosthesis, PERIMOUNT Magna Ease Bioprosthesis, PERIMOUNT Plus Biopro

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3, Ultra 3 Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve and SAPIEN 3 Ultra Transcatheter Heart Valve

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid® Annular Closure Device

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·Onyx™ Liquid Embolic System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve System

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE