Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip™ G4 Clip Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·BOSTON SCIENTIFIC CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (CAROTID WALLSTENT ENDOPROSTHESIS)

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Cordis PRECISE Nitinol Stent 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 ·Carotid Wallstent Monorail Endoprosthesis

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT CARTOID STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE Transcarotid Stent System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip™ G4 Clip Delivery System

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON -TB GOLD

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS