Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS

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 SYNCRA CRT-P

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, SYNCRA CRT-P

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

FDA Pre-Market Approval

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

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, SYNCRA CRT-P

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SELECTION AFM, VITATRON C60 DR, C20 SR, T60 DR, AND T20 SR PACING SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

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

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD CRT-D &EASYTRAK CORONARY VENOUS STEROID ELUTING SINGLE ELCTRODE PACE/SENSE LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY™ MRI Leads, Slit Suture Sleeve Accessory for INGEVITY Leads (Pacing Leads and Accessories)

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

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)

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

FDA Pre-Market Approval

FDA Class 3 ·FINELINE™ II Sterox Leads, Suture Sleeve Accessory for FINELINE II Leads, (Pacing Leads and Accessories)

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

FDA Pre-Market Approval

FDA Class 3 ·ACUITY X4 (Straight,Spiral S, Spiral L) Steroid-eluting, Coronary Venous, QUADRIPOLAR ACE/SENSE LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD