Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ORSIRO Sirolimus Eluting Coronary Stent System and Orsiro Mission Sirolimus Eluting Coronary Stent System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Setrox S53, S60, Safio S 53, S 60, Solia S 45, S 53, S 60, Siello S 45, S 53, s 60, Blind plug BS IS-1

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT)

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

FDA Pre-Market Approval

FDA Class 3 ·EVIA HF, EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Sirolimus Eluting Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, 85, 95, L-75, 85, 95, Sentus ProMRI OTW QP S-75/49, 85/49, 95/49, L-75/49, 85/49, 9/49 and Se

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Enticos 4 DR, Enticos 4 D, Enticos 4 SR, Enticos 4 S, Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6

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

FDA Pre-Market Approval

FDA Class 3 ·Drug Eluting Permanent Left Ventricular Pacemaker Electrode, Pulse Generator Pacemaker Implantable with Cardiac Resynchr

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX VR/DR/HF (-T) ICD'S & CRT-D'S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Pulsar-18 T3

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantav Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, automatic im

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

FDA Pre-Market Approval

FDA Class 3 ·LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF ICD'S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE A-K00.2.U IN THE LEXOS, BELOS AND CARDIAC AIRBAG IMPLANTABLE CARDIOVERTER DEFIBRILLATS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EFH-16; S 60-K; S 60-J; S 60-S

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Permanent, Implantable

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM