Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 540 VR-T DX ICD

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS FAMILY OF PULSE GENERATORS

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMING

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

FDA Pre-Market Approval

FDA Class 3 ·BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Geneerator, Permanent, Implantable

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

FDA Pre-Market Approval

FDA Class 3 ·CELERITY,COROX,ENTOVIS HF(-T),EVIA HF (-T),STRATOS

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 ·Ilivia Neo 7 DR-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TACHOS DR IMPLANTALBLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM

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 Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC AIRBAG / CARDIAC AIRBAG-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX ICDS/COROX OTW UP STEROID

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ICS 3000 IMPLANT CONTROL SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EURO DR, DRT, SR, SR-T; EFFECTA D, DR, S, SR; ELUNA E DR-T PROMRI, 8 DRPROMRI; ELUNA 8 DR-T PROMRI; ELUNA 8 SR-T PROMRI;

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV-T