System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc IgM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·MODULAR ANALYSTICS E170

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE PIECE (NON-CM) TM POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·KABI PHARMACIA ONE PIECE LENSES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS HBSAG TEST SYSTEM

Assay, Interleukin

FDA Pre-Market Approval

FDA Class 3 ·CELLFREE(R) INTERLEUKIN-2 RECEPTOR* BEAD ASSAT KIT

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CM(TM) LENSES MODEL 820A

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

FDA Pre-Market Approval

FDA Class 3 ·Oxford Partial Knee System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE