Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PLATINIUM VR 1210/1240, PLATINIUM DR 1510/1540 (ICD)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Single/Dual Chamber ICD Systems, Bipolar CRT-D Systems and Acticor and Rivacor 1.5 T and 3.0 T ICD and CRT-D Systems

Merlin™

FDA UDI

ST. JUDE MEDICAL, INC.·05414734509725·Software Upgrade Kit

NA

FDA UDI

MEDTRONIC, INC.·00643169513013·PROG 37022 PAT ENS ULTRA/ACTIVA 60601-11

NA

FDA UDI

MEDTRONIC, INC.·00643169974807·ENS 37022 PAT PROG RESTORE US GRC

N/A

FDA UDI

MEDTRONIC, INC.·00763000404413·ENS 37022 EXTERNAL STIM DBS EMANUAL EN

NA

FDA UDI

MEDTRONIC, INC.·00613994972286·PRGM 37022 ENS ULTRA/ACTIVA FLEX

Merlin.net

FDA UDI

ST. JUDE MEDICAL, INC.·05414734509732·Patient Interactive Website

N/A

FDA UDI

MEDTRONIC, INC.·00763000245054·ENS 37022 EXTERNAL STIM DBS US PAPER EN

NA

FDA UDI

MEDTRONIC, INC.·00613994752178·ACC 3625 SCREENER BEI REDESIGN US MKT

OMC NI MEDICAL LIMITED

Authorized representative

13 Manufacturers·18 Devices

4K3D Video Microscope HawkSight

FDA UDI

MITAKA KOHKI CO., LTD.·04589698450602·

FDA Pre-Market Approval

CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF4 CRT-D, PROTECTA CRT-D, PROTECTA DF4 CR

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

FDA Pre-Market Approval

FDA Class 3 ·Brava CRT-D, Brava Quad CRT-D, Concerto ICD, Concerto II CRT-D, Consulta CRT-D, InSync II Protect ICD, Maximo II CRT-D,

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

FDA Pre-Market Approval

FDA Class 3 ·MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT-

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

FDA Pre-Market Approval

FDA Class 3 ·MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT-

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

FDA Pre-Market Approval

FDA Class 3 ·Momentum CRT-D, Momentum X4 CRT-D, ICD Inogen CRT-D, ICD Dynagen CRT-D, Vigilant CRT-D, Vigilant X4 CRT-D, Resonate CRT-

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen ICD Devices

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse, Fortify, Fortify Assura, and Quadra Assura MP ICD Devices

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-D, CONCERTO & VARIOUS INSYNC FAMILIES OF ICDS