Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·REGENCY SC, SC+, AND SCX FAMILY OF PULSE GENERATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROTOS DR/CLS AND PROTOS VR/CLS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Tendril STS 2088TC Lead

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG (R)MODEL 3039 FUNCTION PACK

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, Estella DR,

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR/INTEGRITY SR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·APS III MODEL 3500 PROGRAMMER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CARELINK PROGRAMMER (MODEL 2090)/ANALYZER (MODEL 2290)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL K (UNIPOLAR) & M (BIPOLAR) ENDOCARDIAL LEADS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Permanent Implantable, Pulse-Gererator, Pacemaker External, Adapter and Drug Eluting Permanent Right Ve

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis SR, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T,

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA ONE-STEP

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ADDVENT MODEL 2060LR PULSE GENERATOR AV PLUS SINGLE PASS LEAD MODEL 1328C