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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA, ADVISA DR/DR MRI, RELIA IPG'S

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline™ Flex Embolization Device with Shield Technology™, Pipeline™ Vantage Embolization Device with Shield Technology

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS

Electrical Impedance Spectrometer

FDA Pre-Market Approval

FDA Class 3 ·Nevisense

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·AUTOCYTE PREP SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS DS, NAVISTAR DS, EZ STEER DS and CELSIUS FLTR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·COOLFLOW IRRIGATION PUMP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EXTERNAL PULSE GENERATOR

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCULAR CLOSURE DEVICE

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD FOCALPOINT SLIDE PROFILER

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve Evolut R and Evolut PRO System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart G3 Pro Automated External Defibrillator

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis SR, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T,

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM, BX VELOCITY STENT ON RAPTORRAIL TX DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT ON RAPTORRAIL/WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY SYSTEM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter