Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM (VCS)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT CATHETER (4MM)

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·OXFORD PARTIAL KNEE SYSTEM-TIBIAL TRAYS

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ARTEGRAFT BOVINE HETEROGRAFT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·NOVATION CERAMIC AHS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER 8MM AND 4MM NON-NAVIGATIONAL BI-DIRECTIONAL CATHETERS

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

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer™ Septal Occluder, Amplatzer™ Multifenestrated Septal Occluder – “Cribriform”

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer™ Duct Occluder, Amplatzer™ Duct Occluder II, Amplatzer Piccolo™ Occluder

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL CATHETERS

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval

FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·INSTAT COLLAGEN ABSORBABLE HEMOSTAT

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL, SURGICEL NU-KNIT FIBRILLAR ABSORBABLE HEMOSTAT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·MAXUM SYSTEM