Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA Single-Piece Anterior Chamber Intraocular Lens

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·GELSYN-3

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·H55 HYDROPHILIC CONTACT LENS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFOAM® Absorbable Gelatin Sponge

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open-Irrigated Ablation Catheter

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel®, Synergy®, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems, Pisces™, Specify®, and Vectr

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (etafilcon A) Brand Contact Lenses

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor Ablation System, Mara Water Vapor System, Mara Console

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SUPARTZ

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR

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

FDA Pre-Market Approval

FDA Class 3 ·ANTI-HBC IMMULITE ASSAY

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, LL, XIENCE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 2 LV-1, IS-1, 3 LV-1, 3 IS-1 LEFT VENTRICLAR HEART FAILURE LEADS, AND ACUITY SPIRAL LEADS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE NITINOL STENT SYSTEM