1,083 results
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20ms
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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
·Edora 8, Evity 8, Enitra 8, Enticos 8 HF-T QPs,Edora 8, Evity 8, Enitra 8, Enticos 8 HF-Ts and PSW 1601.U Pacemaker/ICD/
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Evolut FX+ TAV, Evolut FX DCS, Evolut FX LS
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Cath
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN 3 Transcatheter Heart Valves
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·COREVALVE (TM) EVOLUTE (TM) R SYSTEM
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards Commander delivery system (Size 29mm)
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·LOTUS Edge Valve System
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Medtronic Evolut R Transcatheter Aortic Valve Replacement System, Medtronic Evolut PRO Transcatheter Aortic Valve Replac
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN 3 Transcatheter Heart Valve
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·CoreValve Evolut R System, CoreValve Evolut PRO and Wvolut PRO+ Transcatheter Aortic Valves (TAV)
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHER HEART VALVE
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Ascendra+ Delivery System; Balloon Aortic Valvuloplasty Catheter; NovaFlex+ Delivery System; Crimper; Edwards Ballon Cat
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Sapien 3 Transcatheter Heart Valve