Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART SD, VIGILA 1CR, VOLTA 1CR, LINOX SMART S DX, PROTEGO SD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CYLOS DR-T PULSE GENERATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PULSE GENERATORS PHILOS II DR-T/CYLOS DR-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·BIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR/SR & PHILOS II DR/SR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

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

FDA Pre-Market Approval

FDA Class 3 ·PSW 2401.U, NEO 2401.U

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Astron Pulsar and Pulsar-18 Stent Systems

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

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR RIGHT ATRIAL PACEMAKER ELECTRODES, DEXTRUS, SETROX, TILDA, SAFIO

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC AIRBAG

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilesto 7 VR-T; Iforia 7 VR-T; Ilesto 5 VR-T; Iforia 5 VR-T; Ilesto 7 VR T DX; Iforia 7 VR-T DX; Ilesto 5 VR-T DX; Iforia

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Iforia 7, Ilesto 5, Iforia 5, Itrevia 7, Iperia 7, Ilivia 7, Intica 7, Intica 5, Inlexa 3, Inventra 7, Itrevia 5, Iperia

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

FDA Pre-Market Approval

FDA Class 3 ·Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T

Defibrillator, Implantable, Dual-Chamber

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 ·CELERITY 2D/3D/PILOT STEROID-ELUTING LV LEAD, COROX (-S/-L) BP STEROID-ELUTING LV LEAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Sirolimus Eluting Coronary Stent System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENTOVIS DR-T,DR,SR-T,SR; ELUNA 8 DR-T PROMRI,DR PROMRI,SR-T PRMRI,SR PROMRI;SETROX S53,S60;SAFIO S53,S60

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX ICDS AND CRT-DS