Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LEGACY D, LEGACY S, LEGACY II, VISA, CAPSURE PACING LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 2 IS-1 CORONARY VENOUS BIPOLAR PACE/SENSE LEADS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MynxGrip, Mynx Ace, and Mynx Control Vascular Closure Device (VCD)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELID II, STELIX, AND STLIX II STEROID-ELUTING PACING LEADS

Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333

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

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II STEROID-ELUTING PACING LEADS, PASSIVE AND ACTIVE FIXATIONS MODELS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FLEXTEND BIPOLAR ELUTING EXTENDABLE/RETRACTABLE PACING LEADS,MODELS 4086, 4087, 4088

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX, SWEET PICOTIP RX, FLEXTEND FAMILIES OF PACING LEADS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, 4194 AND LEFT VENTRICULAR PACING LEAD, 4193

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/TRANSVENE DEFIBRILLATION LEAD/LEAD END PIN CAP/UPSIZING SLEEVE

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

FDA Pre-Market Approval

FDA Class 3 ·QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS

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

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX, SWEET PICOTIP Rx, and FLEXTEND Pacing Lead Families

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS