Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Trifecta™ Valve with Glide Technology™

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Trifecta Valve with Glide Technology (Trifecta GT) Trifecta Valve.

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THIN LINE AND FINELINE PACING LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS,ENERGEN,INCEPTA,PUNCTUA CRT-DS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·AORTIC VALVED GRAFT WITH MEADOX(R) HEMASHIELD(R)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RX5000 PROGRAMMER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS/LIVIAN/CONTAK RENEWAL/CONTAK RENEWAL 3 RF

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS FAMILY

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD/CD2/RENEWAL/EASYTRAK

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONTRAK RENEWAL TR/TR2 PULSE GENERATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL DEFECT OCCLUDER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NG3 EXTENDED LIFE ICD: DYNAGEN, INOGEN, ORIGEN, NG2 5 MINI ICD DYNAGEN, INOGEN,

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV FOR ASTRID