Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·St. Jude Medical Mechanical heart Valves

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Lotrafilcon B soft contact lenses for extended wear

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Sapien 3 Transcatheter Heart Valve, Sapien 3 Ultra Transcatheter Heart Valve, Commander Delivery System, Edwards eSheath

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form

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

FDA Pre-Market Approval

FDA Class 3 ·Therapy Dual 8 Ablation Catheter and Therapy 8mm Thermistor Ablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTAPRO Rotational Atherectomy System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Phylax AV ICD System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Sofport® Advanced Optics Posterior Chamber Intraocular Lens (IOL)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG,

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYMOVIS®

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR Mutation Test and cobas EGFR Mutation Test, v2.0

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor, Arctic Front Advance (AFA) CryoAblation Catheters

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator)

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·AngioSculpt PTCA Scoring Balloon Catheter