Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRTD, Amplia MRI Quad, Brava CRT-D, Brava CRT-D, Brava Quad CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Clari

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI, Cobalt XT MRI, Crome MRI ICD, Crome MRI ICD,Evera MRI DF-1,Evera MRI DF-1

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS PROSTETIC HEART VALVE (CPHV)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·NU VASIVE PCM CERVICAL DISC SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALCON LADARVISION 4000 EXCIMER LASER SYSTEM-

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella CP with SmartAssist

Mitral Valve Repair Devices

FDA Pre-Market Approval

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

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT(R) VISCOELASTIC SOLUTION

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip Clip Delivery System (NTR and XTR)

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip G4 System

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP DELIVERY SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag Circulatory Support System

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Astron

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

FDA Pre-Market Approval

FDA Class 3 ·Open-Irrigated Cardiac Ablation Catheters

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Mission Sirolimus Eluting Coronary Stent System