Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·BETA-CATH XL DELIVERY CATHETER - 60 MM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3091B IOL /W 5.0 MM OPTICS

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF ENHANCER 7 FRENCH, 5 MM ABLATION CATHETER

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE 60 MM BETA-CATH 5 FR SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR 4 MM BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR 4 MM BI DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION CORONARY STENT SYSTEM - 2.75 MM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Master Series Mechanical Heart Valve with Silzone Coating, Expanded Polyester Cuff with Silzone Coating, HP Cuff wit

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS OPEN PIVOT? BILEAFLET HEART VALVE 35 MM MITRAL VALVE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SJM MODEL 3510 PROGRAMMER(FOR ATLAS II CRT-D)/MERLIN MODEL 3650 PROGRAMMER( FOR ATLAS II & PROMOTE CRT-D)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM

Electrical Tumor Treatment Fields

FDA classification

FDA Class 3 ·Electrical Tumor Treatment Fields

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 ABLATION CATHETER, THERAPY 8 MM THERMISTOR , SAFIRE TX ABLATION CATHETERS & GENERATORS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, RayOne Aspheric

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens and RayOne Aspheric