Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Kappa 700/600 Series Pulse Generators and Model 9953 Software

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

FDA Pre-Market Approval

FDA Class 3 ·Steroid TIP(TM) Model 4503 & 4003 Transvenous Pacing

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Model 5071 Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Medtronic PCD Tachyarrhythmia Control System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Versatrax Model 7000 Universal A-V Pulse Generator

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Starfix Model 4195 Lead

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Activitrax Models 8400, 8402, 8403

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV-ICD System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Synergyst II Pulse Generator Models 7070 & 7071

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Medtronic.Kappa 400 Series Pacemakers

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

FDA Pre-Market Approval

FDA Class 3 ·Capsure SP, Capsure, Capsure 2 Leads, Excellence S, Impulse, Impulse II Excellence SS, Leads

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

FDA Pre-Market Approval

FDA Class 3 ·Medtronic (R) CapSure (R) EPI Pacing Lead

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2100 SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 4000+ BONE HEALING SYSTEM