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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AID-B/BR AND VENTAK ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX, VENTAK MINI FAMILIES OF ICDS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Akreos® Posterior Chamber Intraocular Lens (IOL)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM/ANCURE ILIAC BALLOON CATHETER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Electrode

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Conformable Gore® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Valiant Thoratic Stent Graft with Captivia Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip™ G4 Clip Delivery System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTEK RELIANCE DF1/IS-1 AND RELIANCE 4-SITE LEAD FAMILIES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Sapien 3 Transcatheter Heart Valve

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP NT CLIP DELIVERY SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY CORONARY STENT SYSTEMS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS TORIC CALCULATOR

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE