Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MODEL 74001 1X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION;MODEL 74002 2X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD, DYNAGEN ICD, INOGEN ICD, ORIGEN ICD

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·BILEAFLET-CENTER OPENING CARDIAC VALVE

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACTIVITRAX MODELS 8400, 8402, 8403

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire IV IPG

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·ProACT Adjustable Continence Therapy for Men

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENRHYTHM IPG& ADAPTA/VERSA/SENSIA FAMILY

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·FINELINE,FINELINE II

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO CRT-D

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPI UNIPOLAR & BIPOLAR LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI SURESCAN IPG AND PACING SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova Vascular Self Expanding Stent with Delivery System

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ALTRUA™ 2, ESSENTIO™, PROPONENT™, ACCOLADE™

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System