Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALO, FORMIO, ESSENTO, ACCOLADE, PROPONENT Families of Pacemaker Devices

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

FDA Pre-Market Approval

FDA Class 3 ·CRT-D Resynchronization Devices COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM,

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

FDA Pre-Market Approval

FDA Class 3 ·CRT-P Resynchronization Devices INVIVE, INTUA, VISIONIST, VALITUDE

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·SOFT ACRYLIC MULTIFOCAL ARRAY 2 (MODELS AA40E AND AA50) AND REZOOM (MODEL NXG1) INTRAOCULAR LENSES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PERCIVA, RESONATE, MOMENTUM, VIGILANT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE WAVE COMMUNICATOR (MODEL 6498)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant™ VR, Neutrino™ NxT VR, Gallant™ VR, Entrant™ VR, Avant™ DR, Neutrino™ NxT DR, Gallant™ DR, Entrant™ DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant™ VR, Avant™ DR, Neutrino™ NxT VR, Neutrino™ NxT DR, Gallant™ VR, Gallant™ DR, Entrant™ VR, Entrant™ DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Neutrino NxT VR, Gallant VR, Entrant VR, Neutrino NxT DR, Gallant DR, Entrant DR, Avant VR, Avant DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant™ VR, Neutrino™ NxT VR, Gallant™ VR, Entrant™ VR, Avant™ DR, Neutrino™ NxT DR, Gallant™ DR, Entrant™ DR

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AMO REZOOM INTRAOCULAR LENS (IOL) MODEL NXG1

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

FDA Pre-Market Approval

FDA Class 3 ·Unify ,Unify Assura, Quadra Assura, Quadra Assura MP, Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Neutrino NxT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Fortify, Fortify Assura, Ellipse, Neutrino NxT VR, Gallant VR, Entrant VR, Neutrino NxT DR, Gallant DR, Entrant DR, Avan

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR and Entrant DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous ICD Devices: EMBLEM S-ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker Devices - INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI