Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM2/VITALITY

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify Disc

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System, Propel Contor

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE/LPS-MOBILE BEARING KNEE SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·PLATINIUM CRT-D 1711/1741

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACYSOF MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENSES

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Intera 3000 Hepatic Artery Infusion Pump

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM/VITALITY

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS MODEL 2625 AND 6625

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE LEAD (DF4)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR

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 BIOPROSTHESES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM MRI S-ICD; EMBLEM S-ICD

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALNAT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES