41 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·PG VALITUDE CRT-P, PG VISIONIST CRT-P
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 SR, ALTRUA 2 DR
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT-
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ANEURX AAADAVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EVERA S D DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·REVO MRI SURESCAN IPG
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Cerene Cryotherapy Device
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·FRONTIER/FRONTIER II FAMILY OF CRT-PS
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·Covera Vascular Covered Stent
Aortic Stent
FDA Pre-Market Approval
FDA Class 3
·Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·Covera Vascular Covered Stent
Iliac Covered Stent, Arterial
FDA Pre-Market Approval
FDA Class 3
·LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·THINLINE II/FINELINE II STEROX PACING LEADS