Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR MODELS 2490C AND 2491 DDMA, CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MYCARELINK

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SENSE MRI SURESCAN LEAD MODELS 4074 AND 4574.

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935 (DF-1), SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947 (DF-1)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI XT DR SURESCAN MODEL DDMB1D1, EVERA MRI XT VR SURESCAN MODEL DVMB1D1, EVERA MRI S DR SURESCAN MODEL DDMC3D1, E

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG,ADVISA DR MRI IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Montage and Precision Montage MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·IsoFlex

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI SURESCAN PACING SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR 2490G

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI

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

FDA Pre-Market Approval

FDA Class 3 ·Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D, Implantable Cardioverter Defibrillators with Cardiac Resynchroniz

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·PROMETRA PROGRAMMABLE IMPLANTABLE PUMP

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

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

FDA Pre-Market Approval

FDA Class 3 ·Quadripolar CRT-D Systems