Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PULSAR, PULSAR MAX, INSIGNIA, ALTRUA, ADVANTIO & INGENIO PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AND VENTAK MINI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, EASYTRAK, LIVIAN, COGNIS, ACUITY SPIRAL, ENERGEN, PUNCTUA, & INCEPTA CRT-D'S

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN/INCEPTA/ENERGEN/PUNCTUA ICDS

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS/INCEPTA/ENERGEN/PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis with and without Inhibizone Treatment

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spexctra WaveWriter Spinal Co

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Series Product Line/Artificial Urinary sphincter with and without InhibiZone Treatment

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·FARAPULSE Pulsed Field Ablation System

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Series Product Line/ Artificial Urinary Sphincter with and without InhibiZone Treatment

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·MAXUM SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S ICD )

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