Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

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 ·Elecsys Anti-HBc IgM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS 150A 150SE ULTRA VOILET-ABSORB. POSTERIOR

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS (WITH HEPARIN BIOACTIVE SURFACE)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

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

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 AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·FORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface