Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META MV MODEL 1202 CARDIAC PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNCHRONY PACING SYS. MODEL 3039 FUNCTION PACK

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AUTIMA PACING SYSTEM (META DDD MODEL 1230)

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINLINE II/FINELINE II STEROX PACING LEADS

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

FDA Pre-Market Approval

FDA Class 3 ·THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY+ and INGEVITY MRI Pace/Sense leads

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

FDA Pre-Market Approval

FDA Class 3 ·Medtronic (R) CapSure (R) EPI Pacing Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacing System and Micra AV TPS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CPI DEXATIP(TM) MODEL 4262 TRANSVENOUS PACING LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Revo MRI SureScan IPG and Pacing System

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

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, LED VENTRICULAR PACING LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW-L BP LEFT VENTRICULAR PACING LEAD

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·POLY-SAFE(TM) A-TRACK(TM) PACING LEADS

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

FDA Pre-Market Approval

FDA Class 3 ·THIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R)SP MODELS 4024/4524 PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE Z MODELS 5034/5534/5033 PACING LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES/MODELS OF TILDA BRADYCARDIA PACING LEADS