Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR CATHETER, NAVISTAR RMT CATHETER, EZ STEER NAY CATHETER, BIOSENSE WEBSTER CABLES

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY SR/DR

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS 55 (OCUFILCON D) UV BLOCKER IMT SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX AND OTW DUET CORONARY STENT SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G Insulin Pump

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BOSTON EQUALENS/BOSTON EQUALENS II

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX Reflux Management System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FOCUS NIGHT AND DAY (LOTRAFILCON A AND B) EXTENDED WEAR SOFT CONTACT LENSES

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown Orbital Atherectomy Device (OAD)

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY/SOLUS/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMICAL ANGIOPLASTLY BALLOON CATHETER

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·ADEZA FETAL FIBRONECTIN EIK

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACA MULTI-LINK & DUET CSS