BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P110021 · Decision Oct 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
    PMA Number
    P110021
    Device Class
    FDA Class 3
    Product Code
    NPT
    Generic Name
    Aortic valve, prosthesis, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    October 19, 2012
    Date Received
    May 2, 2011
    Expedited Review
    Y
    Docket Number
    12M-1088

    Advisory Committee Statement

    APPROVAL FOR EDWARDS SAPIEN¿ TRANSCATHETER HEART VALVE MODEL 9000TFX, SIZES 23MM AND 26MM, AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES LISTED ABOVE. THIS DEVICE IS INDICATED FOR THE FOLLOWING:TRANSAPICAL - THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX, SIZES 23 MM AND 26 MM, IS INDICATED FOR TRANSAPICAL DELIVERY IN PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVESTENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY AND WITH EJECTION FRACTION >= 20% WHO HAVE BEEN EXAMINED BY A HEART TEAM INCLUDING AN EXPERIENCED CARDIAC SURGEON AND A CARDIOLOGIST AND FOUND TO BE OPERATIVE CANDIDATES FOR AORTIC VALVE REPLACEMENT BUT WHO HAVE A SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >= 8% OR ARE JUDGED BY THE HEART TEAM TO BE AT A >=15% RISK OF MORTALITY FOR SURGICAL AORTIC VALVE REPLACEMENT. THE ASCENDRA BALLOON CATHETER IS INDICATED FOR THE TRANSAPICAL DELIVERY OF THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE. TRANSFEMORALTHE EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX, SIZES 23 MM AND 26 MM, ISINDICATED FOR TRANSFEMORAL DELIVERY IN PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVESTENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY AND WITH EJECTION FRACTION >20% WHO HAVE BEENEXAMINED BY A HEART TEAM INCLUDING AN EXPERIENCED CARDIAC SURGEON AND A CARDIOLOGIST AND FOUND TOEITHER BE: 1) INOPERABLE AND IN WHOM EXISTING CO-MORBIDITIES WOULD NOT PRECLUDE THE EXPECTEDBENEFIT FROM CORRECTION OF THE AORTIC STENOSIS; OR 2) BE OPERATIVE CANDIDATES FOR AORTIC VALVE REPLACEMENT BUT WHO HAVE A SOCIETY OF THORACIC SURGEONS PREDICTED OPERATIVE RISK SCORE > 8% OR ARE JUDGED BY THE HEART TEAM TO BE AT A >15% RISK OF MORTALITY FOR SURGICAL AORTIC VALVE REPLACEMENT.THE RETROFLEX 3 DELIVERY SYSTEM IS INDICATED FOR THE TRANSFEMORAL DELIVERY OF THE EDWARDSSAPIEN TRANSCATHETER HEART VALVE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NPT Aortic Valve, Prosthesis, Percutaneously Delivered