Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·HEPACOAT ON BX SONIC BALLOON-EXPANDABLE STENT OTW DELIVERY SYSTEM

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R))

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·HEPACOAT ON BX SONIC BALLOON-EXPANDABLE TENT OTW DELIVERY SYSTEM

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·UROVYSION BLADDER CANCER KIT ASSAY

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT W/HEPACOAT ON RAPTOR/ON SONIC OTW/ON RAPTORRAIL STENT DELIVERY SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Diva Platform Implantable Pulse Generators; PRO VIT Application Software

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Attain Ability Model 4196 Lead

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

FDA Pre-Market Approval

FDA Class 3 ·Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators with Cardiac Resynchicnization

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Selectsecure Lead Model 3830

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Medtronic(R) Legend Plus(TM) Pulse Generator

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Insync Biventrical Pacing System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI Surescan IPG and Pacing System

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Medtronic(R) Transvene Lead System

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Micra Transcatheter Pacemaker System