Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Astron Peripheral Self-Expanding Nitinol Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

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, Entico

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS FAMILY, EVIA FAMILY, ENTOVIS FAMILY

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1901.U

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC AIRBAG (-T) ICDS & BELOS VR (-T) ICDS & TMS 1000 PLUS PROGRAMMING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Home Monitoring System Version 3.52.0

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SELECTED MODELS OF SINGLE CHAMBER ICD DEVICES

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

FDA Pre-Market Approval

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Tupoa LV/ATX & Kronos LV-T / CRT-D & Corox OWT Steroid LV Pacing Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Defibrillator, implantable, dual-chamber

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IFORIA 5/7, ILESTO 57/, INVENTRA 7, IPERIA 5/7, ITREVIA 5/7, ILIVIA 5/7, INTICA 5/7, INLEXA 5/7, LUMAX 300/340 and 500/5

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Permanent Defibrillator Electrodes

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Permanent Defibrillator Electrodes

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Astron Peripheral Self-Expanding Nitinol Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·Home Monitoring System Version 3.56.0

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR/SR/PHILOS II DR /SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/ENTOVIS DR PULSE GENERATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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