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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura, Fortify

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura, Fortify

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

FDA Pre-Market Approval

FDA Class 3 ·Neutrino™ NxT HF, Avant™ HF, Gallant ™ HF, Entrant™ HF

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

FDA Pre-Market Approval

FDA Class 3 ·Avant™ HF, Neutrino™ NxT HF, Gallant™ HF, Entrant™ HF

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

FDA Pre-Market Approval

FDA Class 3 ·Avant, Gallant, Entrant, Neutrino NxT Family of CRT-Ds

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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF,

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

FDA Pre-Market Approval

FDA Class 3 ·Avant™ HF, Neutrino™ NxT HF, Gallant™ HF, Entrant™ HF

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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny family of Pacemakers

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

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

FDA Pre-Market Approval

FDA Class 3 ·Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+

RectalPro 75 Endorectal Balloon

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

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