System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEP TEST

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE(VAD) SYSTEM

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx®

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Gore Helex Septal Occluder, Gore CardioForm Septal Occluder

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Gore Tag Thoracic Endoprosthesis

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·Gore Viabahn VBX Balloon Expandable Endoprosthesis

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin Bioactive Surface

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·Gore Viatorr Tips Endoprosthesis; Gore Viatorr Tips Endoprosthesis with Controlled Expansion

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch Endoprsthesis

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Gore Tigris Vascular Stent

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin Bioactive Surface

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MICRA TRANSCATHETER PACING SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION DEVICE FITTING SOFTWARE (SCLIN)