Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV ICD

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR & DR-T, Evity 8 DR-T,Enitra 8 DR-T, Enticos 8 DR-T, Edora 8 SR-T and SR, Evity 8 SR-T, Enitra 8 SR-T,Enticos

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1601.U Pacemaker/ICD/CRT non implanted components

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solar Bipolar CRT-P,

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

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD INOGEN VR DF4, ICD INOGEN VR DF1/IS1, ICD INOGEN DR DF4/IS1, ICD INOGEN DR DF1/IS1, ICD DYNAGEN VR DF1/IS1, ICD DYNA

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 Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (ICS 3000 802.U/2)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (ICS 3000 802.U/2)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PROTECTA XT DR D314DRM, PROTECTA DR D334DRM, CARDIOVERTER DEFIBRILLATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (ICS 3000 802.U/2)

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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PROTECTA XT CRT-D D314TRM AND PROTECTA CRT-D D334 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV AND LV-T PULSE GENERATORS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CARELINK MONITOR MODEL 2490C, CARDIOSIGHT READER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·XELOS DR-T ICD SYSTEM AND APPLICATION SOFTWARE VERSION A-K00.3.U