Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·GORE Carotid Stent

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE, VIATORR TIPS Endoprosthesis - with Controlled Expansion

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR & TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER IOLS (MODELS AAB00 & ZCB00)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS SS-25NB & SS-26NB SILICONE ELASTOMERIC POST

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·JJSV’s intraocular lenses (IOLs)

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 1-Piece IOL with TECNIS® iTEC Preloaded Delivery System Model PCB00, TECNIS Multifocal 1-PC IOL with TECNIS® iTEC

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Healon Ultimate Dual Pack, HEALON, HEALON GV, HEALON5, and Healon Duet Dual Pack products

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AMO TECNIS LENS MODEL ZA9003

FDA Pre-Market Approval

TECNIS 1- PIECE IOL WITH TECNIS ITEC, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC, AND TECNIS TORIC 1-PIECE IOL

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 3PC MULTIFOCAL

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)