Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·9767/9767L PROGRAMMING HEAD AND MODEL9990 DESKTOP SOFTWARE

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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SECURA/VIRTUOSO II/MAXIMO II ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI SURESCAN IPG AND PACING SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,VITATRON IMPULSE II LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

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

FDA Pre-Market Approval

FDA Class 3 ·Cobalt XT HF Quad CRT-D MRI SureScan (DTPA2QQ, DTPA2Q1); Cobalt XT HF CRT-D MRI SureScan (DTPA2D4 and DTPA2Dl); Cobalt H

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD, SERVICE KIT-PACEMAKER REPAIR KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD,VR ICD, XT DR ICD,VR ICD, MAXIMO II ICD, PROTECTA ICD,XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYMBIOS, SYNERGYST

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EPICARDIAL PATCH LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MARQUIS VR/DR ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead,Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena B

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead