Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers, INGEVITY MRI Lead, Slit Sutu

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM, PRIZM II CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONTRAK RENEWAL TR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 & LV-1

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SWEET PICOTIP RX/FLEXTEND/SWEET TIP RX/FIXATION TOOL

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

FDA Pre-Market Approval

FDA Class 3 ·ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677, 4678

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

FDA Pre-Market Approval

FDA Class 3 ·EPT-1000 CARDIAC ABLATION SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software

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

FDA Pre-Market Approval

FDA Class 3 ·IntellaNav MiFi Open-Irrigated Ablation Catheters, IntellaTip MiFi Open-Irrigated Ablation Catheters, IntellaNav Open-Ir

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM, PRIZM HE, PRIZM 2, VITALITY, VITALITY 2, VITALITY AVT, VITALITY DS, VITALITY EL, VITALITY HE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN, INOGEN, ORIGEN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP NT CLIP DELIVERY SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·REGENT/STANDARD/MASTERS MECHANICAL HEART VALVES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LD Ingevity Plus AF IS1

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST