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

FDA Pre-Market Approval

FDA Class 3 ·Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Tupos LV/ATx and Kronos LV-T CRT-D System

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

FDA Pre-Market Approval

FDA Class 3 ·BELOS AND LEXOS DR/DR-T/VR-T, LUMOS DR/VR-T, XELOS DR-T ICD'S

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

FDA Pre-Market Approval

FDA Class 3 ·EVIA CRT-P'S

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

FDA Pre-Market Approval

FDA Class 3 ·Eluna / Epyra / Etrinsa

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEMNOS (TM) CARDIAC PACEMAKER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TACHOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND PROGRAMMER SOFTWARE VERSION A-K00.1.U/5

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·STEROX S AND DEXTRUS FAMILY OF IMPLANTABLE PACEMAKER PULSE GENERATORS AND PROGRAMMERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Stylet Catheter, Implantable Cardioverter Defibrillator, Implantable Dual-Chamber Defibrillator, Defibrillator Automatic

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMESSENGER (CM LLT, CM T LINE AND CM II)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELOX, TILDA, SOLOX

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello S 45 leads and Solia S 45 leads

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Defibrillator, Implantable Dual-Chamber

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T (

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Plexa ProMRI DF-1 S DX 65/17, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI S 60,

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

FDA Pre-Market Approval

FDA Class 3 ·Evia HF/ HF-T; Entovis HF/ HF-T; Edora 8 HF-T; Enitra 8 HF-T; Enticos 8 HF-T; Evity 8 HF-T; Etrinsa 8 HF T; Epyra 8 HF-T

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