Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·REVEAL LINQ SOFTWARE MODEL SWO26

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE 4-SITE

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF(R) (GRAFTSKIN)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 2.5 SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 Dual ISH DNA Probe Cocktail

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current+, Fortify, Fortify Assura, Ellipse

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

FDA Pre-Market Approval

FDA Class 3 ·Latitude™ NXT Patient Management System (COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE,

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 SMALL VESSEL CORONARY STENT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX AAADVANTAGE XCELERANT HYDRO DELIVERY SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·BELOTERO BALENCE DERMAL FILLER

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

FDA Pre-Market Approval

FDA Class 3 ·LUMAS FAMILY