Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER XP RF ABLATION CATHETER

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE FIX/NOVUS LEAD DRUG COMBINATION/SURE FIX/VITATRON PIROUET+/VITATRON CRYSTALINE LEAD DRUG COMBINATION

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER PFO OCCLUDER

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense Lead

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF Conductr, RF Contactr, RF Enhancr II, RF Marinr, RF Unipolar Marinr

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA SC/SOLETRA/KINETRA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, RELIA, SENSIA, & VERSA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF Catheter Cables

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA & SYNCRA CRT-PS

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

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

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR MODELS 2490C AND 2491 DDMA, CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MYCARELINK