Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Evia DR,DR-T,SR,SR-T; Entovis DR,DR-T,SR-T; Estella DR,DR-T,SR,SR-T; Effecta D,S; Edora 8 DR, 8 SR; Etrinsa 8 DR-T,SR-T,

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMESSENGER

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

FDA Pre-Market Approval

FDA Class 3 ·Home Monitoring System Version 3.52.0

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

FDA Pre-Market Approval

FDA Class 3 ·STATOS LV/LV-T, EVIA/ENTOVIS HF/HF-T

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY

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

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, and En

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8

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

FDA Pre-Market Approval

FDA Class 3 ·Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Mission Sirolimus Eluting Coronary Stent System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IIivia, 7 HF-T,QP; Intica 7,5 HF-T,QP

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS II FAMILY OF PULSE GENERATORS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Astron Stent System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACTROS, AXIOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, AND PROTOS FAMILIES OF PULSE GENERATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System, Papyrus

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ORSIRO Mission Sirolimus Eluting Coronary Stent System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PSW 1801.U

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

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 CRT-P, Evity 8 CRT-P, and Enitra 8 CRT-P and Corox OTW, Sentus (ProMRI) OTW Drug Eluting Permanent Left Ventricu

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP