Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PSW 1802.U, ACTROS, AXOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, PROTOS, EVIA, ENTOVIS, ECURO, EFFECTA, ESTELLA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora / Enitra /Enticos / Evity PSW 1701.U

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS, CYLOS, EVIA, ESTELLA, EFFECTA FAMILY IMPLANTABLE PULSE GENERATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Plexa S 60, Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa SD 60/16, Plexa ProMRI SD 60/16, Plexa ProMRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PSW 1904.U

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

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·CELERITY 2D 75, 2D 85, 3D75, 3D85, PIOLOT 75,85; COROX OTW 75-UP STEROID, 85-UP, 85-BP, D75-BP

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Defibrillator, implantable, dual-chamber

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

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non-implanted components

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PSW 2301.U, NEO 2301.U

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

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW-L BP LEADS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ORSIRO Sirolimus Eluting Coronary Stent System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX, KRONOS LV-T, LUMAX 300/340 FAMILY OF ICDS AND CRT-DS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T

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

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW (-S) BP STEROID-ELUTING LEADS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Astron Pulsar/Pulsar-18 Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Mission Sirolimus Eluting Coronary Stent System