Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·VENTANA HER2 Dual ISH DNA Probe Cocktail

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SUPARTZ FX, VISCO-3

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) & OTW

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HIGH CYLINDER POWER ACRYSOF IQ TORIC IOLS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Cobas HBV

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX (R) CERAMIC TOTAL HIP SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS & EXPRESS 2 CORONARY STENT SYSTEMS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN XT TRANSCATHETER HEART VALVE

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Concerto II/Consulta/Maximo II/Viva Qu

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-SUPRAANNULAR (S.A.V.) BIOPROSTHESIS

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC / ABLATION CATHETERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 DR/SR IPGS

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE COLLAMER LENS (VISIAN ICL)

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

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·THE AMPLATZER SEPTAL OCCLUDER/AMPLATZER CRIBRIFORM OCCLUDER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM